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

NCT00313547 | Terminated Phase 4

• 3 other identifiers: MHI 05740Pfizer NRA9060008(Investigator initiated study)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Blood pressure; Hypertension; Renin; Aldosterone; Heart rate variability

Outcome Measures

Primary Outcomes (1)

• Heart rate variability

Secondary Outcomes (9)

• Tolerability

• Renin, aldosterone

• MMPs

• Oxidative stress

• Norepinephrine

Interventions

Quinapril 40 mg DRUG

Quinapril 10 mg and amlodipine 5 mg DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Pfizer: collaborator

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

MeSH Terms

Conditions

Hypertension

Interventions

Quinapril; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 10, 2006
• First Posted: April 12, 2006
• Study Start: April 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: March 1, 2008
• Last Updated: May 6, 2008

Record last verified: 2007-08

Locations

CA (1)