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

NCT00313547

Last updated date
Study Location
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
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
  • Drug: Quinapril 40 mg
  • Drug: Quinapril 10 mg and amlodipine 5 mg
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
 (submitted: April 11, 2006)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Michel White, MDMontreal Heart Institute
Principal Investigator:Simon de Denus, B. Pharm, MScFaculty of Pharmacy, University of Montreal/Montreal Heart Institute
Principal Investigator:Jacques de Champlain, MD, PhDFaculty of Medicine, University of Montreal
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