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Evaluating the Link Between Thiazide Medications, the Nervous System, and Diabetes in Individuals With High Blood Pressure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00353652
First Posted: July 19, 2006
Last Update Posted: December 29, 2014
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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Wanpen Vongpatanasin, University of Texas Southwestern Medical Center
Results First Submitted: December 2, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition: Hypertension
Interventions: Drug: Chlorthalidone
Drug: Spironolactone
Drug: Eplerenone
Drug: Quinapril
Drug: Irbesartan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
72 subjects were screened but excluded from study because of failure to meet eligibility criteria.

Reporting Groups
  Description
Chlorthalidone Alone Chlorthalidone: 12.5-25 mg taken orally, once daily
Chlorthalidone Plus Spironolactone

Chlorthalidone: 12.5-25 mg taken orally, once daily

Spironolactone: 50-75 mg taken orally, once daily

Chlorthalidone Plus Irbesartan

Chlorthalidone: 12.5-25 mg taken orally, once daily

Irbesartan: 150 mg taken orally, once daily

Irbesartan

Drug: Irbesartan

150 mg taken orally, once daily

Chlorthalidone Chlorthalidone 12.5-25 mg taken orally daily
Spironolactone Spironolactone 25-75 mg taken orally daily

Participant Flow:   Overall Study
    Chlorthalidone Alone   Chlorthalidone Plus Spironolactone   Chlorthalidone Plus Irbesartan   Irbesartan   Chlorthalidone   Spironolactone
STARTED   17   17   17   7   23   23 
COMPLETED   17   17   17   7   18   18 
NOT COMPLETED   0   0   0   0   5   5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Chlorthalidone Alone Chlorthalidone: 12.5-25 mg taken orally, once daily
Chlorthalidone Plus Spironolactone

Chlorthalidone: 12.5-25 mg taken orally, once daily

Spironolactone: 50-75 mg taken orally, once daily

Chlorthalidone Plus Irbesartan

Chlorthalidone: 12.5-25 mg taken orally, once daily

Irbesartan: 150 mg taken orally, once daily

Irbesartan

Drug: Irbesartan

150 mg taken orally, once daily

Chlorthalidone Chlorthalidone: 12.5-25 mg taken orally, once daily
Spironolactone Spironolactone: 25-75 mg taken orally, once daily
Total Total of all reporting groups

Baseline Measures
   Chlorthalidone Alone   Chlorthalidone Plus Spironolactone   Chlorthalidone Plus Irbesartan   Irbesartan   Chlorthalidone   Spironolactone   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   17   17   7   23   23   104 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.6  (2.3)   50.6  (2.3)   50.6  (2.3)   47  (3)   51  (2)   51  (2)   50.5  (2.3) 
Gender 
[Units: Participants]
             
Female   6   6   6   2   9   9   38 
Male   11   11   11   5   14   14   66 
Region of Enrollment 
[Units: Participants]
             
United States   17   17   17   7   23   23   104 


  Outcome Measures

1.  Primary:   Sympathetic Nerve Activity   [ Time Frame: Measured at 6 months ]

2.  Primary:   24-hour Ambulatory Blood Pressure   [ Time Frame: Measured at 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Primary:   Insulin Sensitivity   [ Time Frame: Measured at 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Primary:   Forearm Blood Flow   [ Time Frame: Measured at 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Primary:   Baroreflex Sensitivity   [ Time Frame: Measured at 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Primary:   C-reactive Protein   [ Time Frame: Measured at 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Primary:   Inflammatory Cytokines   [ Time Frame: Measured at 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Electrolytes   [ Time Frame: Measured at 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Body Weight   [ Time Frame: Measured at 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Wanpen Vongpatanasin
Organization: University of Texas Southwestern Medical Center
phone: 2146458000
e-mail: wanpen.vongpatanasin@utsouthwestern.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Wanpen Vongpatanasin, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00353652     History of Changes
Other Study ID Numbers: 413
R01HL078782-02 ( U.S. NIH Grant/Contract )
First Submitted: July 18, 2006
First Posted: July 19, 2006
Results First Submitted: December 2, 2014
Results First Posted: December 29, 2014
Last Update Posted: December 29, 2014