High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine in the Treatment of High-Risk Hypertensive Patients
NCT00313547
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- 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
- 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.
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| Descriptive Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine in the Treatment of High-Risk Hypertensive Patients | |||||||||
| Official Title ICMJE | 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 | |||||||||
| 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. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 4 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||||||||
| Condition ICMJE | Hypertension | |||||||||
| Intervention ICMJE |
| |||||||||
| Study Arms ICMJE | Not Provided | |||||||||
| Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Terminated | |||||||||
| Estimated Enrollment ICMJE | 40 | |||||||||
| Original Enrollment ICMJE | Same as current | |||||||||
| Actual Study Completion Date ICMJE | March 2008 | |||||||||
| Actual Primary Completion Date | April 2007 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Principal Exclusion Criteria:
| |||||||||
| Sex/Gender ICMJE |
| |||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Canada | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT00313547 | |||||||||
| Other Study ID Numbers ICMJE | MHI 05740 Pfizer NRA9060008 (Investigator initiated study) | |||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | Not Provided | |||||||||
| Study Sponsor ICMJE | Montreal Heart Institute | |||||||||
| Collaborators ICMJE | Pfizer | |||||||||
| Investigators ICMJE |
| |||||||||
| PRS Account | Montreal Heart Institute | |||||||||
| Verification Date | August 2007 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||