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Completed

NCT Number: NCT01556997

Perindopril Amlodipine for the Treatment of 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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XOMA 985

Drug

PERa/AMLb capsule taken once daily by mouth for six weeks

Amlodipine Besylate

Drug

AMLb capsule taken once daily by mouth for six weeks

Perindopril Erbumine

Drug

PERe capsule taken once daily by mouth for six weeks

Primary outcomes

  1. Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).

    Time frame: Day 0 to Day 42

Secondary outcomes

  1. Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).

    Time frame: Day 0 to Day 42

Sponsors and collaborators

Lead sponsor

Symplmed Pharmaceuticals LLC

Industry

Registry information

Official study title

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

Acronym: PATH

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 19, 2012
Registry last updated
Sep 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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