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Trial record 1 of 4 for:    "Gitelman syndrome"
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A Translational Approach to Gitelman Syndrome

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: NCT00822107
Recruitment Status : Completed
First Posted : January 14, 2009
Results First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
Oregon Clinical and Translational Research Institute
Information provided by (Responsible Party):
David Ellison, Oregon Health and Science University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Gitelman Syndrome
Intervention Drug: Hydrochlorothiazide
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Thiazide Response
Hide Arm/Group Description

Hydrochlorothiazide 50 mg will be administered by mouth once.

Hydrochlorothiazide: 50 mg one time

Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Thiazide Response
Hide Arm/Group Description

Hydrochlorothiazide 50 mg will be administered by mouth once.

Hydrochlorothiazide: 50 mg one time

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
42
(38 to 50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
5
 100.0%
Male
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
 100.0%
1.Primary Outcome
Title Chloriuretic Response to a Thiaizde
Hide Description Change from baseline in fractional chloride excretion in response to a single dose of hydrochlorothiazide
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thiazide Response
Hide Arm/Group Description:

Hydrochlorothiazide 50 mg will be administered by mouth once.

Hydrochlorothiazide: 50 mg one time

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: fractional chloride excretion
1.23  (0.93)
Time Frame 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Thiazide Response
Hide Arm/Group Description

Hydrochlorothiazide 50 mg will be administered by mouth once.

Hydrochlorothiazide: 50 mg one time

All-Cause Mortality
Thiazide Response
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Thiazide Response
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Thiazide Response
Affected / at Risk (%)
Total   0/5 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. David H. Ellison
Organization: Oregon Health & Science University
Phone: 5034944465
EMail: ellisond@ohsu.edu
Layout table for additonal information
Responsible Party: David Ellison, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00822107     History of Changes
Other Study ID Numbers: IRB00004529
First Submitted: January 13, 2009
First Posted: January 14, 2009
Results First Submitted: December 28, 2018
Results First Posted: April 5, 2019
Last Update Posted: April 5, 2019