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). )

First Received: April 10, 2006 Last Updated: May 2, 2008 History of Changes

Sponsor:	Montreal Heart Institute
Collaborator:	Pfizer
Information provided by:	Montreal Heart Institute
ClinicalTrials.gov Identifier:	NCT00313547

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study
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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Quinapril hydrochloride Quinapril Amlodipine Amlodipine besylate

U.S. FDA Resources

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

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

Keywords provided by Montreal Heart Institute:

Blood pressure
Hypertension
Renin
Aldosterone
Heart rate variability

Additional relevant MeSH terms:

Vasodilator Agents
Quinapril
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Protease Inhibitors
Amlodipine
Membrane Transport Modulators
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on November 27, 2009