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Clinical trialNCT00582777CompletedPhase 2/PHASE3Interventional

African American Study of Kidney Disease and Hypertension ABPM Pilot Study

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Enrollment180Hypertensive Renal Disease
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

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Sites

16 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Alabama

    Birmingham, Alabama, United States

  • Charles Drew Medical College

    Los Angeles, California, United States

  • University of Southern California

    Los Angeles, California, United States

  • University of California at San Diego

    San Diego, California, United States

  • University of Florida

    Gainesville, Florida, United States

  • University of Miami

    Miami, Florida, United States

  • Emory University

    Atlanta, Georgia, United States

  • University of Chicago

    Chicago, Illinois, United States

  • Johns Hopkins University

    Baltimore, Maryland, United States

  • University of Michigan

    Ann Arbor, Michigan, United States

  • Lenox Hill Hospital

    New York, New York, United States

  • University Hospitals of Cleveland

    Cleveland, Ohio, United States

  • Ohio State University

    Columbus, Ohio, United States

  • Medical University of South Carolina

    Charleston, South Carolina, United States

  • Vanderbilt University

    Nashville, Tennessee, United States

  • Univesity of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ADD On Dosing
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 2007
Primary completion
31 Dec 2008
Completion
31 Dec 2008
Last update posted
16 Apr 2012
Registered enrollment
180
Registry id
NCT00582777

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.