Perindopril Amlodipine for the Treatment of Hypertension

Completed · Phase 3

Conditions studied: Essential Hypertension

In brief

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.

Key facts

Study ID

NCT01556997

Run by

Symplmed Pharmaceuticals LLC

People needed

837

Starts

2012-02-01

Expected to finish

2013-02-01

Last updated by the study team

2015-09-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Essential hypertension
• For female subjects, a negative serum pregnancy test
• Ability to provide written informed consent

You may not qualify if…

• 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

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Muscle Shoals, Alabama, United States
• Study site — Glendale, Arizona, United States
• Study site — Greenbrae, California, United States
• Study site — Los Angeles, California, United States
• Study site — Santa Ana, California, United States
• Study site — Denver, Colorado, United States
• Study site — DeLand, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Gurnee, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Wichita, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Metairie, Louisiana, United States
• Study site — Auburn, Maine, United States
• Study site — Baltimore, Maryland, United States
• Study site — Olive Branch, Mississippi, United States
• Study site — Butte, Montana, United States
• Study site — Berlin, New Jersey, United States
• Study site — Greensboro, North Carolina, United States
• Study site — Hickory, North Carolina, United States

Full record on ClinicalTrials.gov

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