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

May 2, 2008 updated by: Montreal Heart Institute

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Heart rate variability

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

April 10, 2006

First Submitted That Met QC Criteria

April 11, 2006

First Posted (Estimate)

April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

May 6, 2008

Last Update Submitted That Met QC Criteria

May 2, 2008

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHI 05740
  • Pfizer NRA9060008
  • (Investigator initiated study)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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