Perindopril Amlodipine for the Treatment of Hypertension

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the safety and efficacy of a fixed-dose combination drug compared to two other drugs (monotherapies) in controlling hypertension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Symplmed Pharmaceuticals LLC
• Treatments: Amlodipine; Perindopril

Criteria

Inclusion Criteria:

• Essential hypertension

• For female subjects, a negative serum pregnancy test

• Ability to provide written informed consent

Exclusion Criteria:

• Night shift workers whose work hours include midnight to 4:00 a.m.

• Secondary hypertension

• An arm size that precludes the use of the digital blood pressure monitor cuff (arm size > 42 cm)

• Renal dysfunction, severe renal impairment, bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, subjects with only 1 kidney, or post-renal transplant subjects

• Female subjects who are pregnant, planning to become pregnant

• History of malignancy within 5 years

• Primary aldosteronism

• Heart failure (NYHA functional class 3-4), hypertrophic obstructive cardiomyopathy, or hemodynamically relevant stenosis of the aortic or mitral valve

• Significant cardiac arrhythmias, MI, stroke, CABG, PTCA, unstable angina

• Known hypersensitivity to any component of the study drugs

Other protocol-defined inclusion/exclusion criteria may apply