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| Tracking Information | |||||
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| First Received Date ICMJE | October 30, 2006 | ||||
| Last Updated Date | October 30, 2006 | ||||
| Start Date ICMJE | February 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Mean blood pressure measured with 24-hour ambulatory blood pressure monitoring after 12 weeks of follow-up | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Antihypertensive Effectiveness of the Associations of Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril | ||||
| Official Title ICMJE | Hydrochlorothiazide and Amiloride vs Hydrochlorothiazide and Enalapril: a Randomized Clinical Trial of Antihypertensive Effectiveness. | ||||
| Brief Summary | The majority of hypertensive patients require antihypertensive associations to control their blood pressure. Most of clinical trials don’t compare different associations using Hydrochlorothiazide 25 mg as the standard initial therapy and compare the associations using doses that are not equivalent. This randomized trial where patients and investigators are blinded and compares the effectiveness two associations: Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Hypertension | ||||
| Intervention ICMJE | Drug: Amiloride 2,5/d or Enalapril/d 10 mg | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Guerrero P, Fuchs FD, Moreira LM, Martins VM, Bertoluci C, Fuchs SC, Gus M. Blood pressure-lowering efficacy of amiloride versus enalapril as add-on drugs in patients with uncontrolled blood pressure receiving hydrochlorothiazide. Clin Exp Hypertens. 2008 Oct;30(7):553-64. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | |||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00394394 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 04002 | ||||
| Study Sponsor ICMJE | Hospital de Clinicas de Porto Alegre | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Hospital de Clinicas de Porto Alegre | ||||
| Verification Date | October 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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