Trials In Korea Research Articles

Recommendations for carotid stenting in Korea.

Carotid artery angioplasty with stenting (CAS) is being performed in many hospitals in Korea. Most of the guidelines which are being used are similar, but the practical aspects such as techniques are different between hospitals. For example, usage of various protective devices, the oral antiplatelet regimen prior to procedure and placing of temporary pacemaker to prevent bradycardia are different between hospitals. In this article, we summarize and propose the guidelines for CAS which is currently being accepted in Korea. These guidelines may be helpful in providing protocol to neurointerventionalist who perform CAS and to standardize the process including reporting of CAS in the future comparative trials in Korea.

DW1029M, a novel botanical drug candidate, inhibits advanced glycation end-product formation, rat lens aldose reductase activity, and TGF-β1signaling

DW1029M is a botanical extract consisting of Morus bark and Puerariae radix, produced by Dong-Wha Pharmaceutical, for nephroprotective drug development; it has been in phase II clinical trials in Korea. In our mechanistic investigations, we found that DW1029M inhibits advanced glycation end products (AGEs), rat lens aldose reductase (RLAR), and transforming growth factor (TGF)-β1 signaling, all of which are implicated in diabetic complications such as diabetic nephropathy and diabetic retinopathy. DW1029M inhibits AGE formation via Fe(2+) chelation. The extract contains 13 active constituents that inhibit AGE formation, 8 active constituents that inhibit RLAR activity, and 1 inhibitor of TGF-β1 signaling. Our results suggest DW1029M protects against diabetic nephropathy via blockade of AGE formation, RLAR activity, and TGF-β1 signaling.

Early prophylactic versus late selective use of surfactant for respiratory distress syndrome in very preterm infants: a collaborative study of 53 multi-center trials in Korea.

Pulmonary surfactant (PS) therapy was proven to be highly successful for the treatment of respiratory distress syndrome in premature infants. As a results, early prophylactic (EP) PS therapy has been introduced recently in Europe, the US and Korea. However, no multi-center study was compared EP and late selective (LS) PS therapies in Korea. We performed a retrospective multi-center study to compare the outcomes of EP and LS PS therapies in very preterm infants. We analyzed clinical morbidity and mortality for 1,291 infants in 2010 (LS group) and 1,249 infants in 2011 (EP group); the infants were born <30 weeks of gestation and had birth weight ≤1,250 g, and were chosen from 53 neonatal intensive care units in Korea. Compared to the LS group (22.5%), the overall mortality was better in the EP group (19.9%) and there was no increased need for retreatment.There were additional benefits in the EP group such as fewer associated complications. To the best of knowledge, our study is the first nationwide Korean study to compare the outcomes of EP and LS therapies, and it provides evidences that EP PS therapy is important in very preterm infants to improve for survival and reduce morbidities.Graphical

Current Status of Neonatal Clinical Trials in Korea

Current Status of Neonatal Clinical Trials in Korea

Korean citizen participation in criminal trials: The present situation and problems

As citizen participation in criminal trials was first introduced in 2008, it is advisable to keep the present form of an all-citizen jury system rather than introduce or adopt aspects of the Continental mixed tribunal system because the former system makes the best use of the meaning of Article 1 of the Act of Citizen Participation in Criminal Trials in Korea. Though previously professional judges participated in the deliberation process, under the current system, the new procedure should allow only jurors to engage in deliberations and render verdicts, with sentencing still left to professional judges. The new law should also eliminate a consent agreement required for a defendant in jury trial, thereby making jury trial mandatory for certain classes of heinous crimes like murder or even political crimes; juvenile cases, however, may still be excluded from jury trial. In addition, the exclusion right of the court should also be recognized, but the current comprehensive rule (Article 9 (1) (3)) should be eliminated. It is necessary for the jury verdict to have legal binding force such that the prosecutor cannot appeal the acquittal if the verdict was decided unanimously. Lastly, as for the use of victim participation programs, it is enough to simply allow victims to make statements as witness. This year, on March 6, 2013, the revised system of civil participation in criminal trials has been ready based on the evaluation of the current system by the Committee on Civil Judicial Participation, which was comprised of members from the judiciary, the academia, and civil organizations. The new amendment will be submitted to the National Assembly within this year.

Current status of registry of vaccine clinical trials conducted by Korean investigators in ClinicalTrials.gov, database of US National Institutes of Health

PurposePubMed is not only includes international medical journals but also has a registration site for the ongoing clinical trials, such as ClinicalTrials.gov, under the supervision of US National Institutes of Health. We analyzed current status of vaccine clinical trials conducted by Korean investigators in database of ClinicalTrial.gov.Materials and MethodsAs of October 2012, there are total of 72 trials found on registry of vaccine clinical trials conducted by Korean investigators in database of ClinicalTrial.gov. These trials were analyzed and classified by conditions of vaccine clinical trials, biologicals or drugs used in vaccine clinical trials, status of proceeding research, and list of sponsor and collaborators.ResultsTotal 72 trials of vaccine clinical trials conducted by Korean investigators are classified by groups of infection (64 trials), cancer (4 trials), and others (4 trials). Infections group shown are as follows: poliomyelitis, pertussis, diphtheria, tetanus, and Haemophilus influenzae type b (10), influenza (9), human papillomavirus infection (8), pneumococcal vaccine (6), herpes zoster (4), smallpox (4), hepatitis B (4), etc. One trial of each in lung cancer, breast cancer, prostate cancer, and colorectal cancer are shown in cancer group. One trial of each in Crohn's disease, ulcerative colitis, renal failure, and rheumatoid arthritis are shown in other group.ConclusionVaccine clinical trials conducted by Korean investigators in ClinicalTrial.gov reflects the current status of Korean research on vaccine clinical trials at the international level and can indicate research progress. It is hoped that this aids the development of future vaccine clinical trials in Korea.

From Evidence-based Medicine to Personalized Medicine

See Article on Page 259-264 Over the last two decades, many studies have shown the role of the adjuvant chemotherapy in stage III colon cancer [1-8]. With the introduction of excellent cytotoxic agents such as oxaliplatin and irinotecan, the median survival of even stag IV disease has been prolonged by more than 24 months. Based on the National Comprehensive Cancer Network (NCCN) guideline and the recently published Korean guideline, the oxaliplatin-based regimen has been the preferred regimen for stage III colon cancer over a single-agent regimen such as the capecitabine or 5-fluorouracil/leucovorin (FL) regimen. However, some concerns exist regarding the toxicity and the efficacy in adjuvant chemotherapy for stage III colon cancer. Because adjuvant chemotherapy means largely prophylactic chemotherapy rather than therapeutic chemotherapy like palliative chemotherapy, the efficacy of adjuvant chemotherapy should be balanced with its possible side effects, such as peripheral neuropathy or febrile neutropenia. For many years, the ideal duration of adjuvant chemotherapy has been under evaluation. Particularly with regard to the cumulative neuropathic adverse effects of oxaliplatin, a further decrease in the treatment duration is warranted. The SAFFA study showed no differences in term of overall survival between six months of a bolus FL regimen or three months of a protracted FL regimen [3]. However, a shorter adjuvant treatment duration is currently under evaluation in the IDEA program, which includes 12,000 patients from six ongoing trials [9]. Recently, the elderly population has grown remarkably worldwide. South Korea is also one of the countries with a fast-growing elderly population. The subgroup analysis of the NSABP C-07 trial showed a trend towards better disease-free survival in patients younger than age 70 (hazard ratio, 0.80; 95% confidence interval, 0.68 to 0.95; P = 0.013), but no positive effect was evident in older patients with the addition of oxaliplatin to the FL regimen [10]. Even the NCCN guideline recommended that the oxaliplatin-based regimen not be used for elderly patients older than 70 years. Conversely, capecitabine showed a constant efficacy even in elderly patients [11]. Lymph node metastasis is the single most important prognostic factor in colon cancer. It also determines the necessity of adjuvant chemotherapy in colon cancer. In the 7th American Joint Committee on Cancer tumor-node-metastasis staging system [12], the 5-year survival of stage IIIA colon cancer was even better than that of stage IIA colon cancer, which raised the concerns about the necessity of and ideal regimen for adjuvant chemotherapy in stage IIIA colon cancer. In this issue of the Journal of the Korean Society of Coloproctology, an article entitled Oncologic Outcome of Stage IIIA Colon Cancer According to Chemotherapeutic Regimen dealt with this specific concern. Although the study was a single-institution-based retrospective review and included a relatively small number of patients (n = 131) to draw a concrete conclusion, single-agent-based chemotherapeutic regimens (capecitabine or FL) showed 5-year disease free and overall survival rates similar to those of oxaliplatin-based regimens. In stage IIIA colon cancer, the depth of invasion is limited to the muscularis propria, and lymph node metastases are minimal (up to 6 metastatic lymph nodes). Among the eight patients who did not receive the adjuvant chemotherapy, three patients had recurrences during the follow-up, which suggested that adjuvant chemotherapy has a role even in stage IIIA colon cancer. This study suggested the need for further clinical trials in Korea to obtain solid evidence for this specific condition. The incidence of stage IIIA disease is very low, so it takes a long time to collect the patients to identify effective chemotherapeutic agents as in this paper (from 1995 to 2008, only 131 patients were collected). During that time in Korea, the governmental insurance policies changed continuously, so it was hard to measure the real value of the different regimens of adjuvant chemotherapeutic agents. However, this study provides possible clues for individualized or personalized chemotherapy. In the near future, I hope the Korean Society of Coloproctology may have a role in addressing this specific question.

Present Status and Improvement of 'participatory criminal justice system' in Criminal Trials in Korea and Japan

Present Status and Improvement of 'participatory criminal justice system' in Criminal Trials in Korea and Japan

Surfactant Replacement Therapy for RDS: a Collaborative Study of 72 Multi-center Trials in Korea (2010) and a Review of Korean Experiences over 20 Years

Surfactant Replacement Therapy for RDS: a Collaborative Study of 72 Multi-center Trials in Korea (2010) and a Review of Korean Experiences over 20 Years

Effects of Corydaline from Corydalis Tuber on Gastric Motor Function in an Animal Model

The aim of this study was to evaluate the prokinetic and gastric-relaxing effects of the isoquinoline alkaloid corydaline, which was extracted from Corydalis tubers (CT). Corydaline is a marker compound used for quality control of DA-9701, a prokinetic agent formulated from extracts of Pharbitidis semen and Corydalis tuber that is currently in clinical trials in Korea for the treatment of functional dyspepsia (FD). DA-9701 was previously reported to be a potential therapeutic agent for the treatment of abnormalities in gastrointestinal motor function in FD patients; however, the therapeutic effects of corydaline on FD have yet to be demonstrated in an in vivo study. In the current study, oral administration of corydaline not only significantly accelerated gastric emptying in normal rats but also improved delayed gastric emptying to near normal levels. Furthermore, corydaline induced significant gastric relaxation, shifting the pressure-volume curve towards higher volumes compared to controls. These results suggest that corydaline promotes gastric emptying and small intestinal transit and facilitates gastric accommodation.

Current state of clinical trials in Korea

The number of clinical trials sponsored by global pharmaceutical companies performed in countries other than the U.S. and Western Europe has been steadily increasing over the past decade. Among those emerging countries, Korea deserves attention for its rapid growth in the number of trials and sites. As of 2009, Korea was ranked the tenth country in the number of clinical trials registered at http://clinicaltrials.gov. This is remarkable growth given that it was not included in the top 30 countries in 2005. High population density, qualified medical professionals, regulatory changes including Investigational New Drug-New Drug Application (IND/NDA) separation, acceptance of International Conferences on Harmonization-Good Clinical Practices (ICHGCP) by Korea Food&Drug Administration (KFDA), and governmental policies to boost clinical trials were the most influential factors that caused such an outstanding achievement. The Korean National Enterprise for Clinical Trials (KoNECT), an organization founded to lead initiatives to improve the milieu for clinical trials, has been playing a pivotal role in the steering of 15 regional clinical centers designated by the government. Based upon improvements in infrastructure so far, diversity in therapeutic areas and the proportion of early phase trials are expected to grow. Korea has grown to be one of the major countries in the clinical trial market, which was made possible by the cooperation of industry, academia and government. Further investment and efforts to solve current challenges will allow such growth to continue into the next decade.

S27-2 Changing Trends of Clinical Trials in Korea after ICH

S27-2 Changing Trends of Clinical Trials in Korea after ICH

Combination chemotherapy of S-1 and taxanes in Korea

Various combination treatments incorporating S-1 are undergoing clinical trials in Korea, especially combinations with taxane, oxaliplatin, or irinotecan. In a phase I study to estimate the maximum tolerated dose of docetaxel in combination with S-1 administered at a fixed dose of 40 mg/m2 twice daily on days 1–14 of each 3-week cycle in patients with advanced gastric cancer, 60 mg/m2 docetaxel was declared to be the maximum tolerated dose. A phase I/II study of the same schedule of combination chemotherapy with S-1 plus docetaxel reported doses of S-1/docetaxel of 40/75 mg/m2 as the maximum tolerated dose. In a phase I study of S-1 plus weekly docetaxel, the patients received variable doses of docetaxel administered intravenously over 1 h on days 1 and 8 and S-1 administered on days 1–14 of each 3-week cycle. The maximum-tolerated doses of S-1 and docetaxel were determined to be 45 mg/m2 and 35 mg/m2 in this study. A phase I/II study of docetaxel plus S-1 combination chemotherapy from Korea reported a response rate of 43.3%. Also, a phase II study of paclitaxel plus S-1 as first-line therapy in patients with advanced or relapsed gastric cancer showed an overall response rate of 49%. The most frequent significant toxicities in combination chemotherapies with taxane plus S-1 were neutropenia and febrile neutropenia. However, nonhematological toxicities were mild to moderate. A taxane plus S-1 combination regimen could be a new standard regimen for advanced gastric cancer, given its significant activity and favorable toxicity pattern.

Improving the Efficiency of IRB through Joint IRB in Multicenter Clinical Trials in Korea

Improving the Efficiency of IRB through Joint IRB in Multicenter Clinical Trials in Korea

국내 임상시험에 관한 정보 검색의 현황과 개선방안

This year, the number of approved clinical trials in Korea is expected to exceed approximately 300 cases. In regards to this, the Korea Food & Drug Administration provides statistical data and related laws and guidelines on clinical trials through the Release of clinical trials from its website. However, it is not easy to instantly search the basic information related to the study of design, process, subject's consent form, recruitment of subject, and sponsor's contacts information, etc. Accordingly, the ClinicalTrials.gov that is administered by the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) will be compared against the Release of clinical trial of the Korea Food & Drug Administration in order to identify the proper ways to manage and disclose the clinical trial information to the public.

Efficacy and safety profiles of a new S(—)-amlodipine nicotinate formulation versus racemic amlodipine besylate in adult Korean patients with mild to moderate hypertension: An 8-week, multicenter, randomized, double-blind, double-dummy, parallel-group, phase III, noninferiority clinical trial

Background: “Chiral switching” from an existing racemate to a pure enantiomeric compound is a popular theme in drug development, especially when the enantiomer is found to have better efficacy and safety profiles. Amlodipine is a racemic mixture, composed of the S(-)-enantiomer, which is the pharmacologically active isomer, and the R(+)-enantiomer, which is 1000-fold less active. S(-)-amlodipine nicotinate, a chirally switched form of amlodipine nicotinate, has been developed and found to be bioequivalent to amlodipine besylate in Phase I clinical trials in Korea. Objective: The aim of this study was to compare the efficacy and safety profiles of S(-)-amlodipine nicotinate with those of amlodipine besylate in adult Korean patients with mild to moderate hypertension (diastolic blood pressure [DBP] ≥90 mm Hg and ≤109 mm Hg). Methods: This was an 8-week, multicenter, randomized, double-blind, double-dummy, parallel-group, Phase III, noninferiority clinical trial. After an initial 2-week placebo run-in period, patients aged 18 to 75 years with sitting DBP (SiDBP) ≥90 and ≤109 mm Hg at day 0 (baseline) were randomly allocated to receive S(-)-amlodipine nicotinate 2.5 mg QD or amlodipine besylate 5 mg QD for 8 weeks. The dose of study medication was doubled after 4 weeks in patients who had not responded to treatment (SiDBP ≥90 mm Hg). The primary end point was noninferiority of the difference in mean SiDBP from baseline to week 8 for S(-)-amlodipine nicotinate compared with amlodipine besylate. Secondary end points were as follows: (1) noninferiority of the difference in mean sitting systolic blood pressure (SiSBP) from baseline to week 8 between the study groups; and (2) SiDBP response rate (defined as the proportion of patients whose SiDBP was <90 mm Hg or whose SiDBP reduction was ≥10 mm Hg from baseline) after the 8-week treatment. Also, the incidence and severity of adverse events (AEs) and adverse drug reactions (ADRs) were reported. Severe AEs/ADRs were defined as those associated with any of the following: death; an event associated with a high risk of mortality; an event requiring hospitalization; or development of a permanent disability or congenital malformation. Results: One hundred fifty-seven patients were assessed for inclusion in the study. Of these, 124 patients were randomly allocated to receive S(-)-amlodipine nicotinate (42 men, 21 women; mean [SD] age, 52.4 [10.3] years [range, 23–70 years]; weight, 67.7 [10.8] kg [range, 44–92 kg]) or amlodipine besylate (45 men, 16 women; mean [SD] age, 54.5 [10.0] years [range, 30-73]; weight, 68.9 [9.8] kg [range, 49–95 kg]). One hundred sixteen patients completed the study, but 11 patients (8.9%) were dropped from the per-protocol analysis due to violations; therefore, 105 patients were included in the modified intent-to-treat population analysis ( S[-]-amlodipine nicotinate, 55 patients; amlodipine besylate, 50 patients). There were no significant between-group differences in the baseline characteristics. Baseline mean (SD) SiSBP and SiDBP were 142.6 (11.3) and 94.9 (4.8) mm Hg in the S(-)-amlodipine nicotinate group, and 141.8 (8.3) and 96.1 (4.9) mm Hg in the amlodipine besylate group. Mean (SD) changes in SiSBP were 17.6 (11.2) mm Hg in the S(-)-amlodipine nicotinate group and 18.6 (12.3) mm Hg in the amlodipine besylate group. The SiDBP response rates were 92.7% in the S(-)-amlodipine nicotinate group and 88.0% in the amlodipine besylate group. There were no significant between-group differences in the prevalence of AEs and ADRs. In the S(-)-amlodipine nicotinate group, 15 patients (23.8%) reported a total of 28 AEs, and 19 patients (31.1%) reported a total of 27 AEs in the amlodipine besylate group. Six patients (9.5%) in the S(-)-amlodipine nicotinate group and 7 patients (11.4%) in the amlodipine besylate group experienced a total of 19 ADRs (11 and 8, respectively). The most common ADRs were liver enzyme elevation (3/63 [4.8%]) in the S(-)-amlodipine nicotinate group and facial flushing (3/61 [4.9%]) in the amlodipine besylate group. No cases of severe AEs or ADRs were reported in either group. Conclusions: The reduction of SiDBP after 8 weeks of treatment with S(-)-amlodipine nicotinate was noninferior compared with that of racemic amlodipine besylate in these adult Korean patients with mild to moderate hypertension. The SiDBP response rate and the reduction of SiSBP after 8 weeks of treatment with S(-)-amlodipine nicotinate were not significantly different from those with racemic amlodipine besylate. Both treatments were generally well tolerated.

A Study on the System of Public Participation in Criminal Trials in Korea and Japan

A Study on the System of Public Participation in Criminal Trials in Korea and Japan

Assessment of comparative pain relief and tolerability of SKI306X compared with celecoxib in patients with rheumatoid arthritis: A 6-week, multicenter, randomized, double-blind, double-dummy, phase III, noninferiority clinical trial

Background:SKI306X, which consists of biologically active ingredients from Clematis mandsburica, Tricbosantbes kirilowii, and Prunella vulgaris, was developed and tested in preclinical trials in Korea. Those studies found that SKI306X was associated with an anti-inflammatory and analgesic effect, and that it can delay the destruction of cartilage in rheumatoid arthritis (RA). Objective:The aim of this study was to compare the pain relief and tolerability of SKI306X and celecoxib in patients with RA. Methods:This study was a 6-week, multicenter, randomized, double-blind, double-dummy, Phase III, noninferiority clinical trial. Eligible patients were aged 18 to 80 years, had a history of RA with a disease duration of ≥3 months, and were functional American College of Rheumatology (ACR) class I, II, or III before entry. After a washout period of 2 weeks, patients were randomized to SKI306X 200 mg TID or celecoxib 200 mg BID for 6 weeks. The primary end point was a change in patient assessment of pain intensity using a visual analog scale (VAS). The secondary end points were a 20% improvement in response rate as defined by the ACR (ACR20) and the frequency of rescue medication use. Results after 3 and 6 weeks of treatment were compared with baseline and between treatment groups, and all patients were assessed for adverse events (AEs), clinical laboratory data, and vital signs. AEs were identified based on spontaneous reports by patients during interviews conducted by the investigators and the study coordinator. Results:Two hundred twenty-two Korean patients from 7 medical centers were assessed and 183 were enrolled and randomized to 1 of 2 treatment groups. Ninety-one patients (10 male, 81 female; mean [SD] age, 52.13 [12.64] years; mean [SD] duration of RA, 9.08 [10.23] years; no. [%] of ACR class I, II, and III, 13 [14.29], 44 [48.35] and 34 [37.36] patients, respectively) received SKI306X 200 mg TID and 92 patients (10 male, 82 female; mean [SD] age, 51.78 [10.94] years; mean [SD] duration of RA, 8.78 [7.78] years; no. [%] of ACR class I, II, and III, 14 [15.22], 44 [47.83], and 34 [36.96] patients, respectively) received celecoxib 200 mg BID. An analysis of the change in reported pain intensity as determined by VAS (mm) score between baseline and week 3 (mean [SD], 13.64 [16.62] vs 14.45 [15.89]), and between baseline and week 6 (18.4 [20.8] vs 17.9 [19.1], respectively) suggested that SKI306X was not inferior to celecoxib. The number of patients who achieved ACR20 response rate was not significantly different between the SKI306X group and the celecoxib group at week 3 (16/87 [18.4%] vs 24/87 [27.6%], respectively) and at week 6 (29/87 [33.3%] vs 29/87 [33.3%]). The frequency of rescue medication use was not significantly different between the SKI306X group and celecoxib group at week 3 (54/87 [62.1%] vs 47/87 [54.0%], respectively) or week 6 (57/87 [65.5%] vs 49/87 [56.3%]). Drug-related AEs were reported by 27 (29.7%) patients in the SKI306X group and 22 (23.9%) patients in the celecoxib group. The most frequent drug-related AEs were epigastric pain (9/91 [9.9%]) in the SKI306X group and glutamyltranferase elevation (4/92 [4.3%]) in the celecoxib group. No significant between-group differences were observed in the prevalence of drug-related clinical- or laboratory-determined AEs. Conclusion:The results of this study suggest that SKI306X was generally well tolerated and not inferior to celecoxib in regard to pain relief in these Korean patients with RA.

Results of a multicenter, 8-week, parallel-group, randomized,double-blind, double-dummy, phase III clinical trial to evaluate the efficacy and tolerability of amlodipine maleate versus amlodipine besylate in Korean patients with mild to moderate hypertension

Background: Recently, amlodipine maleate was developed and tested in preclinical and Phase I clinical trials in Korea. The studies found pharmacokinetics and pharmacodynamics similar to those of amlodipine besylate. Objective: The aim of this study was to compare the efficacy and tolerability of amlodipine maleate with those of amlodipine besylate in Korean patients with mild to moderate hypertension. Methods: This was a multicenter, 8-week, parallel-group, randomized, double-blind, double-dummy, Phase III clinical trial. Eligible patients were Korean, aged 18 to 75 years, had hypertension, and were either taking antihypertensive medications or had a documented sitting diastolic blood pressure of 90 to 109 mm Hg. After a washout period of 2 weeks, patients were randomized to amlodipine maleate or amlodipine besylate for 8 weeks. In both groups, the medications were initiated at 5 mg QD. At day 29, the medication dose was increased to 10 mg QD if sitting diastolic blood pressure (SiDBP) was ≥90 mm Hg. Results: One hundred eighteen patients were enrolled. Fifty-seven patients received amlodipine maleate (29 men, 28 women; mean [SD] age, 49.0 [11.4] years) and 61 received amlodipine besylate (35 men, 26 women; mean [SD] age, 51.6 [9.4] years). Baseline mean (SD) values for sitting systolic blood pressure and SiDBP were 152.0 (12.2) mm Hg and 98.1 (5.6) mm Hg, respectively, for the amlodipine maleate group and 153.4 (14.0) mm Hg and 98.1 (5.5) mm Hg, respectively, for the amlodipine besylate group. In this population, amlodipine maleate was not inferior to amlodipine besylate: the lower limit of the 2-sided 95% CI for the treatment difference in SiDBP was greater than −4 mm Hg. The between-group difference in SiDBP response rate (the proportion of patients who experienced adequate SiDBP reductions) did not reach statistical significance: 85.7% (42/49) for the amlodipine maleate group and 91.8% (45/49) for the amlodipine besylate group. Compliance rates were similar between groups, with mean (SD) compliance rates of 97.4% (2.8%) and 97.1% (3.6%) in the amlodipine maleate and amlodipine besylate groups, respectively. Also, there were no significant differences in the incidences of drug-related clinical and laboratory adverse events; the most common were headache, flushing, facial edema, and paresthesia. Conclusion: In this population, the efficacy and tolerability observed with amlodipine maleate were similar to those seen with amlodipine besylate.

Current Conditions of Clinical Trials in Korea.

Current Conditions of Clinical Trials in Korea.