Perindopril Amlodipine for the Treatment of Hypertension

Essential Hypertension Clinical Trial

— PATH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556997
• Other study ID #: X985400
• Status: Completed
• Phase: Phase 3
• First received: March 15, 2012
• Last updated: September 8, 2015
• Start date: February 2012
• Est. completion date: February 2013

Study information

• Verified date: August 2015
• Source: Symplmed Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 837
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Symplmed Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).		Day 0 to Day 42	No
Secondary	Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).		Day 0 to Day 42	No