Perindopril Amlodipine for the Treatment of Hypertension (PATH)

Symplmed Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: Perindopril Erbumine; Drug: XOMA 985; Drug: Amlodipine Besylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01556997

X985400

Details and patient eligibility

About

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.

Enrollment: 837 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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837 participants in 3 patient groups

XOMA 985

Experimental group

Description:

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

Treatment:

Drug: XOMA 985

Amlodipine Besylate (AMLb)

Active Comparator group

Treatment:

Drug: Amlodipine Besylate

Perindopril Erbumine (PERe)

Active Comparator group

Treatment:

Drug: Perindopril Erbumine