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

This study has been terminated.
(Very difficult to recruit patients/slow recruitment(2 patients in nearly 2 years).)
Sponsor:
Collaborator:
Pfizer
Information provided by:
Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT00313547
First received: April 10, 2006
Last updated: May 2, 2008
Last verified: August 2007
  Purpose

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 Intervention Phase
Hypertension
Drug: Quinapril 40 mg
Drug: Quinapril 10 mg and amlodipine 5 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:
  • Heart rate variability

Secondary Outcome Measures:
  • Tolerability
  • Renin, aldosterone
  • MMPs
  • Oxidative stress
  • Norepinephrine
  • Lactate
  • Exercise tolerance at 20 and -8 degree celsius
  • Blood pressure
  • Impact of selected pharmacogenetic polymorphisms

Estimated Enrollment: 40
Study Start Date: April 2006
Study Completion Date: March 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313547

Locations
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Montreal Heart Institute
Pfizer
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00313547     History of Changes
Other Study ID Numbers: MHI 05740, Pfizer NRA9060008, (Investigator initiated study)
Study First Received: April 10, 2006
Last Updated: May 2, 2008
Health Authority: Canada: Health Canada

Keywords provided by Montreal Heart Institute:
Blood pressure
Hypertension
Renin
Aldosterone
Heart rate variability

Additional relevant MeSH terms:
Coronary Artery Disease
Hypertension
Glucose Intolerance
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Amlodipine
Quinapril
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014