Perindopril Amlodipine for the Treatment of Hypertension

Phase 3

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: XOMA 985; Drug: Perindopril Erbumine; Drug: Amlodipine Besylate

• Registration Number: NCT01556997
• Lead Sponsor: Symplmed Pharmaceuticals LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-15
• Study First Submitted QC: 2012-03-15
• Study First Posted: 2012-03-19
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2015-07-28
• Results First Submitted QC: 2015-07-28
• Status Verified: 2015-08
• Results First Posted: 2015-08-25
• Last Update Submitted: 2015-09-08
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 837

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
XOMA 985	XOMA 985	fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)
Perindopril Erbumine (PERe)	Perindopril Erbumine	-
Amlodipine Besylate (AMLb)	Amlodipine Besylate	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).	Day 0 to Day 42