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

An 8 Weeks, Multi-Center, Randomized, Double Blinded, Comparative Phase 3 Clinical Trial to Assess the Efficacy and Safety of S-Amlodipine Gentisate Compared to Amlodipine Besylate in Patients With Mild-to-Moderate Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00289406

Enrollment

110

Registered

2006-02-09

Start date

2006-01-31

Completion date

2006-02-28

Last updated

2007-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension

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.

Interventions

DRUGS-amlodipine gentisate

DRUGAmlodipine besylate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The difference in mean changes from baseline in through sitting diastolic blood pressure after 8 weeks of treatment	—

Secondary

Measure	Time frame
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	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026