High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine in the Treatment of High-Risk Hypertensive Patients
Information source: Montreal Heart Institute
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Quinapril 40 mg (Drug); Quinapril 10 mg and amlodipine 5 mg (Drug)
Phase: Phase 4
Sponsored by: Montreal Heart Institute
Official(s) and/or principal investigator(s):
Michel White, MD, Principal Investigator, Affiliation: Montreal Heart Institute
Simon de Denus, B. Pharm, MSc, Principal Investigator, Affiliation: Faculty of Pharmacy, University of Montreal/Montreal Heart Institute
Jacques de Champlain, MD, PhD, Principal Investigator, Affiliation: Faculty of Medicine, University of Montreal
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.
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 design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: Heart rate variability
Exercise tolerance at 20 and -8 degree celsius
Impact of selected pharmacogenetic polymorphisms
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 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
- 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
- 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.
Locations and Contacts
Montreal Heart Institute, Montreal, Quebec H1T 1C8, Canada
Starting date: April 2006
Ending date: March 2008
Last updated: May 2, 2008