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Perindopril Amlodipine for the Treatment of Hypertension (PATH)

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ClinicalTrials.gov Identifier: NCT01556997
Recruitment Status : Completed
First Posted : March 19, 2012
Results First Posted : August 25, 2015
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: XOMA 985 Drug: Amlodipine Besylate Drug: Perindopril Erbumine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 837 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP). [ Time Frame: Day 0 to Day 42 ]

Secondary Outcome Measures :
  1. Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP). [ Time Frame: Day 0 to Day 42 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556997


  Show 48 Study Locations
Sponsors and Collaborators
Symplmed Pharmaceuticals LLC

Responsible Party: Symplmed Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01556997     History of Changes
Other Study ID Numbers: X985400
First Posted: March 19, 2012    Key Record Dates
Results First Posted: August 25, 2015
Last Update Posted: September 28, 2015
Last Verified: August 2015

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