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Ramipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension

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NCT00355589

Last updated on October 13, 2019
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FOR MORE INFORMATION
Study Location
Cahaba Research Inc.
Birmingham, Alabama, 35242 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension, High Blood Pressure
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Previously diagnosed, or newly diagnosed essential hypertension. Blood pressure must
be within a minimum and maximum range prior to drug treatment.

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

- Inability to discontinue all prior antihypertensive medications

- Heart failure

- History of stroke, myocardial infarction, or chest pain within 3 years, or an abnormal
heart rhythm

- Liver or kidney disease

- Certain drugs used to treat other conditions like an enlarged prostate gland, or
arthritis

- Allergy or reactions to certain medications used to treat high blood pressure

Other protocol-defined inclusion and exclusion criteria apply.

NCT00355589
Pfizer
Completed
Ramipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Descriptive Information
Brief Title  ICMJE Ramipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension
Official Title  ICMJE A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Efficacy and Safety of a Combination of Ramipril Plus Hydrochlorothiazide Versus the Component Monotherapies in Subjects With Essential Hypertension
Brief SummaryThe purpose of this study is to determine if there is greater blood pressure reduction using ramipril or hydrochlorothiazide alone or ramipril and hydrochlorothiazide together.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Blood Pressure, High
Intervention  ICMJE Drug: Ramipril and hydrochlorothiazide
Study Arms  ICMJE Not Provided
Publications *White WB, Cleveland JM, Rolleri RL; Ramipril-Hydrochlorothiazide Study Group. Utility of semiautomatic clinic and 24-h ambulatory blood pressure measurements to evaluate combination therapy: the Ramipril-Hydrochlorothiazide Hypertension trial. J Hum Hypertens. 2008 Aug;22(8):559-68. doi: 10.1038/jhh.2008.26. Epub 2008 May 8.


*   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 Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion DateMarch 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Previously diagnosed, or newly diagnosed essential hypertension. Blood pressure must be within a minimum and maximum range prior to drug treatment.

Exclusion Criteria:

  • Inability to discontinue all prior antihypertensive medications
  • Heart failure
  • History of stroke, myocardial infarction, or chest pain within 3 years, or an abnormal heart rhythm
  • Liver or kidney disease
  • Certain drugs used to treat other conditions like an enlarged prostate gland, or arthritis
  • Allergy or reactions to certain medications used to treat high blood pressure

Other protocol-defined inclusion and exclusion criteria apply.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00355589
Other Study ID Numbers  ICMJE K749-06-3001
B5051001 ( Other Identifier: Pfizer )
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS AccountPfizer
Verification DateOctober 2012

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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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