Perindopril Amlodipine for the Treatment of Hypertension
NCT ID: NCT01556997
Last Updated: 2015-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
837 participants
INTERVENTIONAL
2012-02-29
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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XOMA 985
fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)
XOMA 985
PERa/AMLb capsule taken once daily by mouth for six weeks
Amlodipine Besylate (AMLb)
Amlodipine Besylate
AMLb capsule taken once daily by mouth for six weeks
Perindopril Erbumine (PERe)
Perindopril Erbumine
PERe capsule taken once daily by mouth for six weeks
Interventions
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XOMA 985
PERa/AMLb capsule taken once daily by mouth for six weeks
Amlodipine Besylate
AMLb capsule taken once daily by mouth for six weeks
Perindopril Erbumine
PERe capsule taken once daily by mouth for six weeks
Eligibility Criteria
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Inclusion Criteria
* For female subjects, a negative serum pregnancy test
* Ability to provide written informed consent
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Symplmed Pharmaceuticals LLC
INDUSTRY
Responsible Party
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Locations
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Huntsville, Alabama, United States
Muscle Shoals, Alabama, United States
Glendale, Arizona, United States
Greenbrae, California, United States
Los Angeles, California, United States
Santa Ana, California, United States
Denver, Colorado, United States
DeLand, Florida, United States
Fort Lauderdale, Florida, United States
Miami, Florida, United States
Palm Harbor, Florida, United States
Port Orange, Florida, United States
Marietta, Georgia, United States
Gurnee, Illinois, United States
Indianapolis, Indiana, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Metairie, Louisiana, United States
Auburn, Maine, United States
Baltimore, Maryland, United States
Olive Branch, Mississippi, United States
Butte, Montana, United States
Berlin, New Jersey, United States
Greensboro, North Carolina, United States
Hickory, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Kettering, Ohio, United States
Lyndhurst, Ohio, United States
Marion, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Eugene, Oregon, United States
Mt. Pleasant, South Carolina, United States
Simpsonville, South Carolina, United States
Bristol, Tennessee, United States
Austin, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Katy, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Countries
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Other Identifiers
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X985400
Identifier Type: -
Identifier Source: org_study_id
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