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NCT00582777 · ClinicalTrials.gov registry record · Phase 2
African American Study of Kidney Disease and Hypertension ABPM Pilot Study
A Phase 2 study of Hypertensive Renal Disease, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 16
- Study locations
NCT00582777 is a Phase 2 study of Hypertensive Renal Disease that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 180 participants. The trial reports 16 study locations across 12 states.
The verdict
NCT00582777, a Phase 2 study of Hypertensive Renal Disease, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 16
- Study locations
Study Summary
4\. Methods 4a. Overview The study will be conducted in participants in the African-American Study of Kidney Disease (AASK) Cohort study as a randomized three period cross-over trial. Eighty five percent of AASK cohort participants are currently on an ACE inhibitor or angiotensin receptor blocker; the most commonly used ACE inhibitor is ramipril. The new strategies proposed in this pilot study will remain ramipril-based, to maintain the overall blood pressure control achieved thus far. The antihypertensive regimens proposed are as follows: * AM dosing of ramipril and other once daily medications in the participants antihypertensive regimen (termed USUAL), * Bedtime dosing of ramipril and other once a day medications in the participant's antihypertensive regimen (termed HS-DOSING), and * their current antihypertensive regimen plus an additional antihypertensive agent dosed at bed time; the choice of the additional agent will be tailored based on prespecified clinical guidelines (termed ADD-ON DOSING) The "usual arm" serves as the comparator arm. The "hs dosing" and "add-on dosing" arms test practical strategies that could be tested in a subsequent clinical outcomes trial and that could be implemented in clinical practice. We hypothesize that both arms will reduce nocturnal BP in comparison to "usual dosing". We further hypothesize that the "hs dosing" arm will raise daytime BP somewhat but have no net effect on 24 hour BP and that the "add on dosing" arm will have no effect on daytime BP but lower 24 hour BP. This pilot study will begin after the last scheduled AASK Cohort study visit. Eligible participants will be treated for 6 weeks on each of 3 antihypertensive regimens. The sequence of the regimens will be random. Each period of the three periods will have 2 visits, one visit at 3 weeks and one visit at 6 weeks. In the last week of each 6-week period, a 24-hour ABPM will be obtained. The primary outcome variable is nocturnal BP; each pair wise difference bet
Conditions Studied
Interventions
- BEHAVIORAL USUAL - take your BP Meds as you usually do
- BEHAVIORAL HS DOSING
- DRUG ADD On Dosing
Study Locations (16)
California
- University of Southern California - Los Angeles
- Charles Drew Medical College - Los Angeles
- University of California at San Diego - San Diego
Florida
- University of Florida - Gainesville
- University of Miami - Miami
Ohio
- University Hospitals of Cleveland - Cleveland
- Ohio State University - Columbus
Alabama
- University of Alabama - Birmingham
Georgia
- Emory University - Atlanta
Illinois
- University of Chicago - Chicago
Maryland
- Johns Hopkins University - Baltimore
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2007-11 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00582777
The ClinicalTrials.gov registry entry for NCT00582777 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hypertensive Renal Disease appearing as the primary indexed condition, and to 3 interventions - of which USUAL - take your BP Meds as you usually do is the first listed.
NCT00582777 reports 16 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT00582777 about?
NCT00582777 is a clinical study titled "African American Study of Kidney Disease and Hypertension ABPM Pilot Study". 4\. Methods 4a. Overview The study will be conducted in participants in the African-American Study of Kidney Disease (AASK) Cohort study as a randomized three period cross-over trial. Eighty five percent of AASK cohort participants are currently on an ACE inhibitor or angiotensin receptor blocker; ...
What is the current status of trial NCT00582777?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2007-11. Estimated completion is 2008-12.
What conditions does trial NCT00582777 study?
This clinical trial studies the following conditions: Hypertensive Renal Disease.
What interventions are being tested in trial NCT00582777?
The interventions under investigation include: USUAL - take your BP Meds as you usually do (BEHAVIORAL), HS DOSING (BEHAVIORAL), ADD On Dosing (DRUG).
Who is sponsoring clinical trial NCT00582777?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00582777 being conducted?
This trial has 16 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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