Control of Hypertension by Non-Pharmacologic Means
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| First Received Date ICMJE | October 27, 1999 | ||||||||
| Last Updated Date | June 23, 2005 | ||||||||
| Start Date ICMJE | April 1980 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00000498 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Control of Hypertension by Non-Pharmacologic Means | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| Brief Summary | To determine whether blood pressure could be controlled by nutritional-hygienic, non-pharmacologic means in hypertensives treated with drugs in the Hypertension Detection and Follow-up Trial (HDFP). |
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| Detailed Description | BACKGROUND: In the 1970s, many studies had been conducted to control blood pressure in individuals maintained at normotensive levels by the use of weight control and sodium restriction without the concomitant use of anti-hypertensives. The associations between weight, sodium and blood pressure had been well established, but data on the relationship of intervention to blood pressure control had been less so. DESIGN NARRATIVE: Patients were randomly assigned to one of three groups. The 95 patients in Group I were advised to control weight, reduce sodium intake, modify dietary and alcohol intake and were removed from pharmacologic treatment. The 44 patients in Group II were removed from pharmacologic treatment, with no other intervention. The 48 patients in Group III were continued on pharmacologic treatment, with no other intervention. The primary endpoint was the proportion in Groups I and II with diastolic blood pressure less than or equal to 90 mm Hg in the absence of antihypertensive drugs. Secondary endpoints were average diastolic and systolic pressures. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | Not Provided | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Men and women with controlled hypertension. |
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| Gender | Both | ||||||||
| Ages | 40 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Not Provided | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00000498 | ||||||||
| Other Study ID Numbers ICMJE | 17 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Verification Date | January 2000 | ||||||||
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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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