African American Study of Kidney Disease and Hypertension ABPM Pilot Study
Public ClinicalTrials.gov record NCT00582777. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 between the regimens will be calculated.
Study identification
- NCT ID
- NCT00582777
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 180 participants
Conditions and interventions
Conditions
Interventions
- USUAL - take your BP Meds as you usually do Behavioral
- HS DOSING Behavioral
- ADD On Dosing Drug
Behavioral · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2007
- Primary completion
- Nov 30, 2008
- Completion
- Nov 30, 2008
- Last update posted
- Apr 15, 2012
2007 – 2008
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Charles Drew Medical College | Los Angeles | California | 90059 | — |
| University of California at San Diego | San Diego | California | 92161 | — |
| University of Florida | Gainesville | Florida | 32611 | — |
| University of Miami | Miami | Florida | 33101 | — |
| Emory University | Atlanta | Georgia | 30308 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Johns Hopkins University | Baltimore | Maryland | 21205 | — |
| University of Michigan | Ann Arbor | Michigan | 48106 | — |
| Lenox Hill Hospital | New York | New York | 10021 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Vanderbilt University | Nashville | Tennessee | 37232 | — |
| Univesity of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00582777, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 15, 2012 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00582777 live on ClinicalTrials.gov.