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

NCT ID: NCT00313547

Last Updated: 2008-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-03-31

Brief Summary

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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

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Conditions

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Hypertension

Keywords

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Blood pressure Hypertension Renin Aldosterone Heart rate variability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Quinapril 40 mg

Intervention Type DRUG

Quinapril 10 mg and amlodipine 5 mg

Intervention Type DRUG

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Montreal Heart Institute

OTHER

Sponsor Role lead

Principal Investigators

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Michel White, MD

Role: PRINCIPAL_INVESTIGATOR

Montreal Heart Institute

Simon de Denus, B. Pharm, MSc

Role: PRINCIPAL_INVESTIGATOR

Faculty of Pharmacy, University of Montreal/Montreal Heart Institute

Jacques de Champlain, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, University of Montreal

Locations

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Montreal Heart Institute

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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Pfizer NRA9060008

Identifier Type: -

Identifier Source: secondary_id

(Investigator initiated study)

Identifier Type: -

Identifier Source: secondary_id

MHI 05740

Identifier Type: -

Identifier Source: org_study_id