Ramipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension
NCT00355589
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- Previously diagnosed, or newly diagnosed essential hypertension. Blood pressure must be within a minimum and maximum range prior to drug treatment.
- 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.
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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 Summary | The 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 Description | Not 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 |
| ||
| 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 Date | March 2007 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion and exclusion criteria apply. | ||
| Sex/Gender ICMJE |
| ||
| 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 Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Pfizer | ||
| Study Sponsor ICMJE | Pfizer | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Pfizer | ||
| Verification Date | October 2012 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||