Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled, or Complicated Hypertension
| Tracking Information | |
|---|---|
| First Received Date ICMJE | February 25, 2008 |
| Last Updated Date | May 22, 2008 |
| Start Date ICMJE | September 2003 |
| Primary Completion Date | March 2005 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT00684489 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 | Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled, or Complicated Hypertension |
| Official Title ICMJE | Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled or Complicated Hypertension |
| Brief Summary | Plasma renin values determine whether volume or vasoconstrictor (renin) factors predominate in elevating blood pressure and are useful in selecting effective antihypertensive therapy.2,3 The researchers hypothesize that:
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| Detailed Description | Hypertension affects ~25% of adults. The prevalence of hypertension and related complications is greater among the elderly, obese, and ethnic minorities. Unfortunately, hypertension control rates remain in the 25% range and are often significantly lower for the high-risk groups noted.1 Since the high-risk groups are growing more rapidly than the general population, the prevalence of hypertension and associated morbidity and mortality will probably increase sharply in the years ahead unless successful strategies are implemented for dramatically improving blood pressure control. Direct measurements of plasma renin reflect the relative balance between volume (V) and vasoconstrictor (renin [R]) factors underlying the elevated blood pressure in patients with essential hypertension.2 While many antihypertensive medications have effects on both the volume (V) and vasoconstrictor (renin [R]) components of elevated blood pressure, one or the other usually predominates |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Condition ICMJE | Hypertension |
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided |
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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 | 52 |
| Completion Date | September 2005 |
| Primary Completion Date | March 2005 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 21 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Not Provided |
| Administrative Information | |
| NCT Number ICMJE | NCT00684489 |
| Other Study ID Numbers ICMJE | 11023, HR# 11023 |
| Has Data Monitoring Committee | No |
| Responsible Party | Brent M. Egan, MD, Medical University of South Carolina |
| Study Sponsor ICMJE | Medical University of South Carolina |
| Collaborators ICMJE | New York Presbyterian Hospital |
| Investigators ICMJE | Not Provided |
| Information Provided By | Medical University of South Carolina |
| Verification Date | May 2008 |
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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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