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A Study to Evaluate the Efficacy and Safety of Quinapril or Quinapril Plus Hydrochlorothiazide in Patients With Mild to Moderate Hypertension

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Cerrahpasa, Istanbul, 34300 Turkey
Contact
1-800-718-1021
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
19-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- A clinical diagnosis of mild to moderate primary hypertension ("Joint National
Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure,
6th report" Stage I or II)

- Sitting diastolic blood pressure between 90 mmHg and 109 mmHg and systolic blood
pressure between 140 mmHg and 179 mmHg at the end of the no-treatment run-in period

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

- Subjects with secondary hypertension

- Subjects with serious cardiac disease (including myocardial infarction in the last 3
months or decompensated heart failure)

- Subjects who do not accept to stop using any other antihypertensive treatment during
the run-in period and the treatment period of the study

NCT00651287
Pfizer
Completed
A Study to Evaluate the Efficacy and Safety of Quinapril or Quinapril Plus Hydrochlorothiazide in Patients With Mild to Moderate Hypertension

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A Study to Evaluate the Efficacy and Safety of Quinapril or Quinapril Plus Hydrochlorothiazide in Patients With Mild to Moderate Hypertension
A 12-Week Open-Label, Uncontrolled Multicenter Study to Assess the Efficacy and Safety of Quinapril or Quinapril Plus Hydrochlorothiazide in Subjects With Mild to Moderate Hypertension
The purpose of this study is to determine the response rate for the therapeutic goal (diastolic blood pressure (BP) less than 90 mmHg and systolic BP less than 140 mmHg) at Week 6 for quinapril 20 mg and at Week 12 for quinapril 20 mg, quinapril 40 mg, and quinapril 20 mg plus hydrochlorothiazide 12.5 mg; and to determine the mean decrease in diastolic and systolic BP measurements and the change in heart rate at Week 6 and Week 12 compared with baseline.
Not Provided
Interventional
Phase 4
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypertension
  • Drug: quinapril 20 mg
    Quinapril 20 mg oral tablet daily for the first 6 weeks, and if a responder, continued on quinapril 20 mg for an additional 6 weeks
  • Drug: quinapril 20 mg plus hydrochlorothiazide 12.5 mg
    Quinapril 20 mg oral tablet daily for the first 6 weeks; if nonresponder, could be randomized to quinapril 20 mg plus hydrochlorothiazde 12.5 mg daily (Accuzide tablets) for 6 weeks
  • Drug: quinapril 40 mg
    Quinapril 20 mg oral tablet daily for the first 6 weeks; if nonresponder, could be randomized to quinapril 40 mg oral tablet daily for 6 weeks
  • Active Comparator: quinapril 20 mg
    Intervention: Drug: quinapril 20 mg
  • Active Comparator: quinapril 20 mg+hydrochlorothiazide 12.5 mg
    Intervention: Drug: quinapril 20 mg plus hydrochlorothiazide 12.5 mg
  • Active Comparator: quinapril 40 mg
    Intervention: Drug: quinapril 40 mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
June 2004
Not Provided

Inclusion Criteria:

  • A clinical diagnosis of mild to moderate primary hypertension ("Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, 6th report" Stage I or II)
  • Sitting diastolic blood pressure between 90 mmHg and 109 mmHg and systolic blood pressure between 140 mmHg and 179 mmHg at the end of the no-treatment run-in period

Exclusion Criteria:

  • Subjects with secondary hypertension
  • Subjects with serious cardiac disease (including myocardial infarction in the last 3 months or decompensated heart failure)
  • Subjects who do not accept to stop using any other antihypertensive treatment during the run-in period and the treatment period of the study
Sexes Eligible for Study: All
19 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
 
NCT00651287
A9061007
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

BY EMAIL

Contact

[email protected]



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