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Perindopril Amlodipine for the Treatment of Hypertension (PATH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01556997
Recruitment Status : Completed
First Posted : March 19, 2012
Results First Posted : August 25, 2015
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Symplmed Pharmaceuticals LLC

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: XOMA 985 Drug: Amlodipine Besylate Drug: Perindopril Erbumine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 837 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556997


Locations
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United States, Alabama
Huntsville, Alabama, United States
Muscle Shoals, Alabama, United States
United States, Arizona
Glendale, Arizona, United States
United States, California
Greenbrae, California, United States
Los Angeles, California, United States
Santa Ana, California, United States
United States, Colorado
Denver, Colorado, United States
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
United States, Georgia
Marietta, Georgia, United States
United States, Illinois
Gurnee, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kansas
Wichita, Kansas, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Louisiana
Metairie, Louisiana, United States
United States, Maine
Auburn, Maine, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Mississippi
Olive Branch, Mississippi, United States
United States, Montana
Butte, Montana, United States
United States, New Jersey
Berlin, New Jersey, United States
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
United States, Ohio
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Kettering, Ohio, United States
Lyndhurst, Ohio, United States
Marion, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
United States, Oregon
Eugene, Oregon, United States
United States, South Carolina
Mount Pleasant, South Carolina, United States
Simpsonville, South Carolina, United States
United States, Tennessee
Bristol, Tennessee, United States
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
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Norfolk, Virginia, United States
Richmond, Virginia, United States
Sponsors and Collaborators
Symplmed Pharmaceuticals LLC
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Symplmed Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01556997    
Other Study ID Numbers: X985400
First Posted: March 19, 2012    Key Record Dates
Results First Posted: August 25, 2015
Last Update Posted: September 28, 2015
Last Verified: August 2015
Keywords provided by Symplmed Pharmaceuticals LLC:
Hypertension
Essential Hypertension
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Perindopril
Antihypertensive Agents
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors