Perindopril Amlodipine for the Treatment of Hypertension (PATH)

September 8, 2015 updated by: Symplmed Pharmaceuticals LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

837

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States
      • Muscle Shoals, Alabama, United States
    • Arizona
      • Glendale, Arizona, United States
    • California
      • Greenbrae, California, United States
      • Los Angeles, California, United States
      • Santa Ana, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Deland, Florida, United States
      • Ft. Lauderdale, Florida, United States
      • Miami, Florida, United States
      • Palm Harbor, Florida, United States
      • Port Orange, Florida, United States
    • Georgia
      • Marietta, Georgia, United States
    • Illinois
      • Gurnee, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kansas
      • Wichita, Kansas, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Louisiana
      • Metairie, Louisiana, United States
    • Maine
      • Auburn, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Mississippi
      • Olive Branch, Mississippi, United States
    • Montana
      • Butte, Montana, United States
    • New Jersey
      • Berlin, New Jersey, United States
    • North Carolina
      • Greensboro, North Carolina, United States
      • Hickory, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
      • Kettering, Ohio, United States
      • Lyndhurst, Ohio, United States
      • Marion, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Oregon
      • Eugene, Oregon, United States
    • South Carolina
      • Mount Pleasant, South Carolina, United States
      • Simpsonville, South Carolina, United States
    • Tennessee
      • Bristol, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Corpus Christi, Texas, United States
      • Dallas, Texas, United States
      • Ft. Worth, Texas, United States
      • Houston, Texas, United States
      • Katy, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XOMA 985
fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)
Drug: XOMA 985
PERa/AMLb capsule taken once daily by mouth for six weeks
Active Comparator: Amlodipine Besylate (AMLb)
Drug: Amlodipine Besylate
AMLb capsule taken once daily by mouth for six weeks
Active Comparator: Perindopril Erbumine (PERe)
Drug: Perindopril Erbumine
PERe capsule taken once daily by mouth for six weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).
Time Frame: Day 0 to Day 42
Day 0 to Day 42

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).
Time Frame: Day 0 to Day 42
Day 0 to Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Symplmed Pharmaceuticals LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

March 15, 2012

First Submitted That Met QC Criteria

March 15, 2012

First Posted (Estimate)

March 19, 2012

Study Record Updates

Last Update Posted (Estimate)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 8, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X985400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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