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

University of Montreal

Status and phase

Terminated

Phase 4

Conditions

Hypertension

Treatments

Drug: Quinapril 40 mg

Drug: Quinapril 10 mg and amlodipine 5 mg

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00313547

Pfizer NRA9060008

(Investigator initiated study)

MHI 05740

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.