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

Primary Purpose

Hypertension

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Quinapril 40 mg
Quinapril 10 mg and amlodipine 5 mg
Sponsored by
Montreal Heart Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Blood pressure, Hypertension, Renin, Aldosterone, Heart rate variability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Montreal Heart Institute

Outcomes

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

Full Information

First Posted
April 10, 2006
Last Updated
May 2, 2008
Sponsor
Montreal Heart Institute
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00313547
Brief Title
High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine in the Treatment of High-Risk Hypertensive Patients
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 Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Terminated
Why Stopped
Very difficult to recruit patients/slow recruitment(2 patients in nearly 2 years).
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Montreal Heart Institute
Collaborators
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Blood pressure, Hypertension, Renin, Aldosterone, Heart rate variability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Quinapril 40 mg
Intervention Type
Drug
Intervention Name(s)
Quinapril 10 mg and amlodipine 5 mg
Primary Outcome Measure Information:
Title
Heart rate variability
Secondary Outcome Measure Information:
Title
Tolerability
Title
Renin, aldosterone
Title
MMPs
Title
Oxidative stress
Title
Norepinephrine
Title
Lactate
Title
Exercise tolerance at 20 and -8 degree celsius
Title
Blood pressure
Title
Impact of selected pharmacogenetic polymorphisms

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel White, MD
Organizational Affiliation
Montreal Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simon de Denus, B. Pharm, MSc
Organizational Affiliation
Faculty of Pharmacy, University of Montreal/Montreal Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacques de Champlain, MD, PhD
Organizational Affiliation
Faculty of Medicine, University of Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada

12. IPD Sharing Statement

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

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