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:
Montreal Heart Institute
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
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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
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 May 23, 2013