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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00313547
• Other study ID #: MHI 05740
• Secondary ID: Pfizer NRA906000
• Status: Terminated
• Phase: Phase 4
• First received: April 10, 2006
• Last updated: May 2, 2008
• Start date: April 2006
• Est. completion date: March 2008

Study information

• Verified date: August 2007
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: March 2008
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Quinapril 40 mg

• Quinapril 10 mg and amlodipine 5 mg

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Montreal Heart Institute	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability
Secondary	Tolerability
Secondary	Renin, aldosterone
Secondary	MMPs
Secondary	Oxidative stress
Secondary	Norepinephrine
Secondary	Lactate
Secondary	Exercise tolerance at 20 and -8 degree celsius
Secondary	Blood pressure
Secondary	Impact of selected pharmacogenetic polymorphisms