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

SK chemicals

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: S-amlodipine gentisate

Drug: Amlodipine besylate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00289406

SK310_III_2006

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No 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