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High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine in the Treatment of High-Risk Hypertensive Patients

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ClinicalTrials.gov Identifier: NCT00313547
Recruitment Status : Terminated (Very difficult to recruit patients/slow recruitment(2 patients in nearly 2 years).)
First Posted : April 12, 2006
Last Update Posted : May 6, 2008
Sponsor:
Collaborator:
Pfizer
Information provided by:
Montreal Heart Institute

Tracking Information
First Submitted Date  ICMJE April 10, 2006
First Posted Date  ICMJE April 12, 2006
Last Update Posted Date May 6, 2008
Study Start Date  ICMJE April 2006
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2006)
Heart rate variability
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00313547 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2006)
  • Tolerability
  • Renin, aldosterone
  • MMPs
  • Oxidative stress
  • Norepinephrine
  • Lactate
  • Exercise tolerance at 20 and -8 degree celsius
  • Blood pressure
  • Impact of selected pharmacogenetic polymorphisms
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine in the Treatment of High-Risk Hypertensive Patients
Official Title  ICMJE Impact of High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine on Autonomic Regulation and on Sympathetic Activation in Response to Cold Exposure in Hypertensive Patients With Impaired Glucose Tolerance, Diabetes or Coronary Artery Disease
Brief Summary The purpose of this study is to compare the impact of two blood pressure lowering treatments (high dose quinapril versus low dose quinapril plus amlodipine) on variations in heart rate over 24 hours.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Quinapril 40 mg
  • Drug: Quinapril 10 mg and amlodipine 5 mg
Study Arms  ICMJE Not Provided
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 Terminated
Estimated Enrollment  ICMJE
 (submitted: April 11, 2006)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with a documented history of hypertension defined as: SBP > or = 140 mmHg or DBP > or = 90 mmHg if hypertension untreated or patients currently treated for hypertension.
  • Documented CAD or diabetes or impaired glucose tolerance
  • Sinus rhythm

Principal Exclusion Criteria:

  • Previous intolerance or allergic reaction to an ACE inhibitor, an ARB or dihydropyridine calcium channel blocker
  • History of angioedema or cough related to previous ACE inhibitor use.
  • Systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg in untreated patients
  • Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg in patients currently treated by an ACE inhibitor or an ARB
  • Creatinine clearance < 30 ml/min
  • Significant liver dysfunction
  • Current serum potassium > or = 5 mmol/L or a history of marked ACE inhibitor or ARB induced hyperkalemia resulting in either a serum potassium > or = 5.5 mmol/L or a life-threatening adverse event.
  • History of HF or known LVEF < or = 45%
  • Bilateral renal artery stenosis (or unilateral if only one kidney)
  • Unstable angina, myocardial infarction or coronary revascularization within the last 3 months.
  • Connective tissue disease or chronic inflammatory condition
  • Active malignancy
  • Active infection in the last 2 weeks
  • Inability or any contraindication to perform an exercise test.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00313547
Other Study ID Numbers  ICMJE MHI 05740
Pfizer NRA9060008
(Investigator initiated study)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Montreal Heart Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Michel White, MD Montreal Heart Institute
Principal Investigator: Simon de Denus, B. Pharm, MSc Faculty of Pharmacy, University of Montreal/Montreal Heart Institute
Principal Investigator: Jacques de Champlain, MD, PhD Faculty of Medicine, University of Montreal
PRS Account Montreal Heart Institute
Verification Date August 2007

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