Perindopril Amlodipine for the Treatment of Hypertension

Study Overview
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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.

Official Title
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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

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: XOMA 985
* Drug: Amlodipine Besylate
* Drug: Perindopril Erbumine


Participation Criteria
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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 Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XOMA 985<br>fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb) | Drug: XOMA 985<br>* PERa/AMLb capsule taken once daily by mouth for six weeks<br>|
| Active Comparator: Amlodipine Besylate (AMLb)<br> | Drug: Amlodipine Besylate<br>* AMLb capsule taken once daily by mouth for six weeks<br>|
| Active Comparator: Perindopril Erbumine (PERe)<br> | Drug: Perindopril Erbumine<br>* PERe capsule taken once daily by mouth for six weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP). |  | Day 0 to Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP). |  | Day 0 to Day 42 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Essential Hypertension