Perindopril Amlodipine for the Treatment of Hypertension



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:February 2012
End Date:February 2013

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Perindopril Amlodipine for the Treatment of Hypertension (PATH): A Multicenter, Randomized, Double-Blind, Parallel-Group Study Evaluating the Efficacy and Safety of a Fixed-Dose Combination of Perindopril Arginine Plus Amlodipine Besylate Versus Perindopril Erbumine and Amlodipine Besylate in Subjects With Essential Hypertension

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.


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
We found this trial at
48
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