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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Montreal Heart Institute

April 10, 2006
April 12, 2006
May 6, 2008
April 2006
April 2007   (Final data collection date for primary outcome measure)
Heart rate variability
Same as current
Complete list of historical versions of study NCT00313547 on Archive Site
  • Tolerability
  • Renin, aldosterone
  • MMPs
  • Oxidative stress
  • Norepinephrine
  • Lactate
  • Exercise tolerance at 20 and -8 degree celsius
  • Blood pressure
  • Impact of selected pharmacogenetic polymorphisms
Same as current
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High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine in the Treatment of High-Risk Hypertensive Patients
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
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.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Drug: Quinapril 40 mg
  • Drug: Quinapril 10 mg and amlodipine 5 mg
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2008
April 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
MHI 05740
Pfizer NRA9060008
(Investigator initiated study)
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Montreal Heart Institute
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
Montreal Heart Institute
August 2007

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