Perindopril Amlodipine for the Treatment of Hypertension
PATH
1 other identifier
interventional
837
1 country
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2012
Shorter than P25 for phase_3
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 15, 2012
CompletedFirst Posted
Study publicly available on registry
March 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
August 25, 2015
CompletedSeptember 28, 2015
August 1, 2015
1 year
March 15, 2012
July 28, 2015
September 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).
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).
Day 0 to Day 42
Study Arms (3)
XOMA 985
EXPERIMENTALfixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)
Amlodipine Besylate (AMLb)
ACTIVE COMPARATORPerindopril Erbumine (PERe)
ACTIVE COMPARATORInterventions
AMLb capsule taken once daily by mouth for six weeks
PERe capsule taken once daily by mouth for six weeks
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
Muscle Shoals, Alabama, United States
Unknown Facility
Glendale, Arizona, United States
Unknown Facility
Greenbrae, California, United States
Unknown Facility
Los Angeles, California, United States
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Santa Ana, California, United States
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Denver, Colorado, United States
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DeLand, Florida, United States
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Fort Lauderdale, Florida, United States
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Miami, Florida, United States
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Palm Harbor, Florida, United States
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Port Orange, Florida, United States
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Marietta, Georgia, United States
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Gurnee, Illinois, United States
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Indianapolis, Indiana, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Metairie, Louisiana, United States
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Auburn, Maine, United States
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Baltimore, Maryland, United States
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Olive Branch, Mississippi, United States
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Butte, Montana, United States
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Berlin, New Jersey, United States
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Greensboro, North Carolina, United States
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Hickory, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Kettering, Ohio, United States
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Lyndhurst, Ohio, United States
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Marion, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Eugene, Oregon, United States
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Mt. Pleasant, South Carolina, United States
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Simpsonville, South Carolina, United States
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Bristol, Tennessee, United States
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Austin, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Katy, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeff Feldstein, Sr. Vice President and CMO
- Organization
- Symplmed Pharmaceuticals LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2012
First Posted
March 19, 2012
Study Start
February 1, 2012
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
September 28, 2015
Results First Posted
August 25, 2015
Record last verified: 2015-08