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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

April 10, 2006
May 2, 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 ClinicalTrials.gov 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
Not Provided
Not Provided
 
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • Drug: Quinapril 40 mg
  • Drug: Quinapril 10 mg and amlodipine 5 mg
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00313547
MHI 05740, Pfizer NRA9060008, (Investigator initiated study)
Not Provided
Not Provided
Montreal Heart Institute
Pfizer
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