Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pre-ESRD Syndrome in High Risk African Americans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00224939
Recruitment Status : Terminated (Only apx 1/3 of enrolled subjects (signed consent) participated. Futility analysis to show primary endpoint)
First Posted : September 23, 2005
Last Update Posted : January 14, 2010
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information
First Submitted Date  ICMJE September 21, 2005
First Posted Date  ICMJE September 23, 2005
Last Update Posted Date January 14, 2010
Study Start Date  ICMJE July 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pre-ESRD Syndrome in High Risk African Americans
Official Title  ICMJE Pre-ESRD Syndrome in High Risk African American Young Adults
Brief Summary Evaluation of the dipping status of blood pressure (wether blood pressure decreases at night) and renal functional reserve and wether non-dippers (those whose blood pressure does not decrease at night) can be modulated to dippers with potassium treatment.
Detailed Description Evaluation of the dipping status of blood pressure (wether blood pressure decreases at night) and renal functional reserve and wether non-dippers (those whose blood pressure does not decrease at night) can be modulated to dippers with potassium treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Blood Pressure
Intervention  ICMJE Drug: Potassium Chloride
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: September¬†21,¬†2005)
144
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria: 18-35, healthy volunteers, African American

Exclusion Criteria: Active medical conditions, prescription drug therapy other than birth control

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00224939
Other Study ID Numbers  ICMJE DK 62714 (terminated)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elizabeth B Ripley, MD Virginia Commonwealth University
PRS Account National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP