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Perindopril Amlodipine for the Treatment of Hypertension (PATH)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
XOMA (US) LLC
ClinicalTrials.gov Identifier:
NCT01556997
First received: March 15, 2012
Last updated: August 21, 2012
Last verified: March 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by XOMA (US) 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 ]

Estimated Enrollment: 816
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
Estimated 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556997

  Show 48 Study Locations
Sponsors and Collaborators
XOMA (US) LLC
  More Information

No publications provided

Responsible Party: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT01556997     History of Changes
Other Study ID Numbers: X985400
Study First Received: March 15, 2012
Last Updated: August 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by XOMA (US) LLC:
Hypertension
Essential Hypertension

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

ClinicalTrials.gov processed this record on May 23, 2013