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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

Tracking Information
First Submitted Date  ICMJE March 15, 2012
First Posted Date  ICMJE March 19, 2012
Results First Submitted Date  ICMJE July 28, 2015
Results First Posted Date  ICMJE August 25, 2015
Last Update Posted Date September 28, 2015
Study Start Date  ICMJE February 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2012)
Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP). [ Time Frame: Day 0 to Day 42 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP). [ Time Frame: Day 0 to Day 42/End of Treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2012)
Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP). [ Time Frame: Day 0 to Day 42 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP). [ Time Frame: Day 0 to Day 42/End of Treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perindopril Amlodipine for the Treatment of Hypertension
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Essential Hypertension
Intervention  ICMJE
  • Drug: XOMA 985
    PERa/AMLb capsule taken once daily by mouth for six weeks
  • Drug: Amlodipine Besylate
    AMLb capsule taken once daily by mouth for six weeks
  • Drug: Perindopril Erbumine
    PERe capsule taken once daily by mouth for six weeks
Study Arms  ICMJE
  • Experimental: XOMA 985
    fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)
    Intervention: Drug: XOMA 985
  • Active Comparator: Amlodipine Besylate (AMLb)
    Intervention: Drug: Amlodipine Besylate
  • Active Comparator: Perindopril Erbumine (PERe)
    Intervention: Drug: Perindopril Erbumine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2013)
837
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2012)
816
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01556997
Other Study ID Numbers  ICMJE X985400
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Symplmed Pharmaceuticals LLC
Study Sponsor  ICMJE Symplmed Pharmaceuticals LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Symplmed Pharmaceuticals LLC
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP