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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
Information provided by:
Montreal Heart Institute

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Quinapril 40 mg Drug: Quinapril 10 mg and amlodipine 5 mg Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2006
Primary Completion Date : April 2007
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Heart rate variability

Secondary Outcome Measures :
  1. Tolerability
  2. Renin, aldosterone
  3. MMPs
  4. Oxidative stress
  5. Norepinephrine
  6. Lactate
  7. Exercise tolerance at 20 and -8 degree celsius
  8. Blood pressure
  9. Impact of selected pharmacogenetic polymorphisms

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00313547

Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
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

ClinicalTrials.gov Identifier: NCT00313547     History of Changes
Other Study ID Numbers: MHI 05740
Pfizer NRA9060008
(Investigator initiated study)
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: May 6, 2008
Last Verified: August 2007

Keywords provided by Montreal Heart Institute:
Blood pressure
Heart rate variability

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