Perindopril Amlodipine for the Treatment of Hypertension (PATH)
Primary Purpose
Essential Hypertension
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
XOMA 985
Amlodipine Besylate
Perindopril Erbumine
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension focused on measuring Hypertension, Essential Hypertension
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
XOMA 985
Amlodipine Besylate (AMLb)
Perindopril Erbumine (PERe)
Arm Description
fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)
Outcomes
Primary Outcome Measures
Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).
Secondary Outcome Measures
Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).
Full Information
NCT ID
NCT01556997
First Posted
March 15, 2012
Last Updated
September 8, 2015
Sponsor
Symplmed Pharmaceuticals LLC
1. Study Identification
Unique Protocol Identification Number
NCT01556997
Brief Title
Perindopril Amlodipine for the Treatment of Hypertension
Acronym
PATH
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 Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Symplmed Pharmaceuticals LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Hypertension, Essential Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
837 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XOMA 985
Arm Type
Experimental
Arm Description
fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)
Arm Title
Amlodipine Besylate (AMLb)
Arm Type
Active Comparator
Arm Title
Perindopril Erbumine (PERe)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
XOMA 985
Intervention Description
PERa/AMLb capsule taken once daily by mouth for six weeks
Intervention Type
Drug
Intervention Name(s)
Amlodipine Besylate
Intervention Description
AMLb capsule taken once daily by mouth for six weeks
Intervention Type
Drug
Intervention Name(s)
Perindopril Erbumine
Intervention Description
PERe capsule taken once daily by mouth for six weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).
Time Frame
Day 0 to Day 42
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Huntsville
State/Province
Alabama
Country
United States
City
Muscle Shoals
State/Province
Alabama
Country
United States
City
Glendale
State/Province
Arizona
Country
United States
City
Greenbrae
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Santa Ana
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Deland
State/Province
Florida
Country
United States
City
Ft. Lauderdale
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Palm Harbor
State/Province
Florida
Country
United States
City
Port Orange
State/Province
Florida
Country
United States
City
Marietta
State/Province
Georgia
Country
United States
City
Gurnee
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Metairie
State/Province
Louisiana
Country
United States
City
Auburn
State/Province
Maine
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Olive Branch
State/Province
Mississippi
Country
United States
City
Butte
State/Province
Montana
Country
United States
City
Berlin
State/Province
New Jersey
Country
United States
City
Greensboro
State/Province
North Carolina
Country
United States
City
Hickory
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Kettering
State/Province
Ohio
Country
United States
City
Lyndhurst
State/Province
Ohio
Country
United States
City
Marion
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Eugene
State/Province
Oregon
Country
United States
City
Mount Pleasant
State/Province
South Carolina
Country
United States
City
Simpsonville
State/Province
South Carolina
Country
United States
City
Bristol
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Corpus Christi
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Ft. Worth
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Katy
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Perindopril Amlodipine for the Treatment of Hypertension
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