Efficacy and Safety Study of S-Amlodipine Gentisate Compared to Amlodipine Besylate to Treat Mild-to-Moderate Hypertension

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00289406
• Lead Sponsor: SK Chemicals Co., Ltd.

Brief Summary

The goal of this study is to compare the antihypertensive effect and tolerability of S-amlodipine gentisate with those of amlodipine besylate in patients with mild to moderate hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study Completion: 2006-02
• Study First Submitted: 2006-02-07
• Study First Submitted QC: 2006-02-07
• Study First Posted: 2006-02-09
• Status Verified: 2006-09
• Last Update Submitted: 2007-03-05
• Last Update Posted: 2007-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• patients are required to have a mean cuff sitting diastolic blood pressure of ≥90 and ≤109 mmHg after successful completion of the 2-week placebo run-in period

Exclusion Criteria

• any serious disorder that could limit the ability of the patient to participate in the study
• significant cardiovascular disease (angina, myocardial infarction, cerebrovascular disease, or significant arrhythmia in the preceding 6 months)
• uncontrolled diabetes mellitus (serum glucose level ≥140 mg/dl)
• insulin dependent diabetes mellitus (type I)
• secondary hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The difference in mean changes from baseline in through sitting diastolic blood pressure after 8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Mean changes in sitting systolic blood pressure; response rate (defined as the proportion of patients whose sDBP was ≤90mmHg or whose sDBP had decreased from baseline by ≥10 mmHg); changes in triglyceride and total cholesterol level of blood sample

Trial Locations

Locations (1)

SKChemicals; 🇰🇷 Seoul, Korea, Republic of