Perindopril Amlodipine for the Treatment of Hypertension (PATH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Symplmed Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT01556997
First received: March 15, 2012
Last updated: September 8, 2015
Last verified: August 2015
  Purpose
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.

Condition Intervention Phase
Essential Hypertension
Drug: XOMA 985
Drug: Amlodipine Besylate
Drug: Perindopril Erbumine
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Symplmed Pharmaceuticals LLC:

Primary Outcome Measures:
  • Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP). [ Time Frame: Day 0 to Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP). [ Time Frame: Day 0 to Day 42 ] [ Designated as safety issue: No ]

Enrollment: 837
Study Start Date: February 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: XOMA 985
fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)
Drug: XOMA 985
PERa/AMLb capsule taken once daily by mouth for six weeks
Active Comparator: Amlodipine Besylate (AMLb) Drug: Amlodipine Besylate
AMLb capsule taken once daily by mouth for six weeks
Active Comparator: Perindopril Erbumine (PERe) Drug: Perindopril Erbumine
PERe capsule taken once daily by mouth for six weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556997

  Show 48 Study Locations
Sponsors and Collaborators
Symplmed Pharmaceuticals LLC
  More Information

Responsible Party: Symplmed Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01556997     History of Changes
Other Study ID Numbers: X985400 
Study First Received: March 15, 2012
Results First Received: July 28, 2015
Last Updated: September 8, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Symplmed Pharmaceuticals LLC:
Hypertension
Essential Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Perindopril
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 26, 2016