Perindopril Amlodipine for the Treatment of Hypertension

NCT ID: NCT01556997

Last Updated: 2015-09-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

837 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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XOMA 985

fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)

Group Type EXPERIMENTAL

XOMA 985

Intervention Type DRUG

PERa/AMLb capsule taken once daily by mouth for six weeks

Amlodipine Besylate (AMLb)

Group Type ACTIVE_COMPARATOR

Amlodipine Besylate

Intervention Type DRUG

AMLb capsule taken once daily by mouth for six weeks

Perindopril Erbumine (PERe)

Group Type ACTIVE_COMPARATOR

Perindopril Erbumine

Intervention Type DRUG

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

Intervention Type DRUG

Amlodipine Besylate

AMLb capsule taken once daily by mouth for six weeks

Intervention Type DRUG

Perindopril Erbumine

PERe capsule taken once daily by mouth for six weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Symplmed Pharmaceuticals LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Huntsville, Alabama, United States

Site Status

Muscle Shoals, Alabama, United States

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Glendale, Arizona, United States

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Greenbrae, California, United States

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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

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Countries

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United States

Other Identifiers

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X985400

Identifier Type: -

Identifier Source: org_study_id

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