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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 10, 2006

Last Updated Date

May 2, 2008

Start Date ^ICMJE

April 2006

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Heart rate variability

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00313547 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Quinapril 40 mg
Drug: Quinapril 10 mg and amlodipine 5 mg

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

March 2008

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00313547

Other Study ID Numbers ^ICMJE

MHI 05740, Pfizer NRA9060008, (Investigator initiated study)

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Montreal Heart Institute

Collaborators ^ICMJE

Pfizer

Investigators ^ICMJE

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

Information Provided By

Montreal Heart Institute

Verification Date

August 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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