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

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ClinicalTrials.gov Identifier: NCT00353652
Recruitment Status : Completed
First Posted : July 19, 2006
Results First Posted : December 29, 2014
Last Update Posted : December 29, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Wanpen Vongpatanasin, University of Texas Southwestern Medical Center

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
Enrollment 176

Recruitment Details  
Pre-assignment Details 72 subjects were screened but excluded from study because of failure to meet eligibility criteria.
Arm/Group Title Chlorthalidone Alone Chlorthalidone Plus Spironolactone Chlorthalidone Plus Irbesartan Irbesartan Chlorthalidone Spironolactone
Hide Arm/Group Description Chlorthalidone: 12.5-25 mg taken orally, once daily

Chlorthalidone: 12.5-25 mg taken orally, once daily

Spironolactone: 50-75 mg taken orally, once daily

Chlorthalidone: 12.5-25 mg taken orally, once daily

Irbesartan: 150 mg taken orally, once daily

Drug: Irbesartan

150 mg taken orally, once daily

Chlorthalidone 12.5-25 mg taken orally daily Spironolactone 25-75 mg taken orally daily
Period Title: Overall Study
Started 17 17 17 7 23 23
Completed 17 17 17 7 18 18
Not Completed 0 0 0 0 5 5
Arm/Group Title Chlorthalidone Alone Chlorthalidone Plus Spironolactone Chlorthalidone Plus Irbesartan Irbesartan Chlorthalidone Spironolactone Total
Hide Arm/Group Description Chlorthalidone: 12.5-25 mg taken orally, once daily

Chlorthalidone: 12.5-25 mg taken orally, once daily

Spironolactone: 50-75 mg taken orally, once daily

Chlorthalidone: 12.5-25 mg taken orally, once daily

Irbesartan: 150 mg taken orally, once daily

Drug: Irbesartan

150 mg taken orally, once daily

Chlorthalidone: 12.5-25 mg taken orally, once daily Spironolactone: 25-75 mg taken orally, once daily Total of all reporting groups
Overall Number of Baseline Participants 17 17 17 7 23 23 104
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 17 participants 7 participants 23 participants 23 participants 104 participants
50.6  (2.3) 50.6  (2.3) 50.6  (2.3) 47  (3) 51  (2) 51  (2) 50.5  (2.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 17 participants 7 participants 23 participants 23 participants 104 participants
Female
6
  35.3%
6
  35.3%
6
  35.3%
2
  28.6%
9
  39.1%
9
  39.1%
38
  36.5%
Male
11
  64.7%
11
  64.7%
11
  64.7%
5
  71.4%
14
  60.9%
14
  60.9%
66
  63.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 17 participants 17 participants 7 participants 23 participants 23 participants 104 participants
17 17 17 7 23 23 104
1.Primary Outcome
Title Sympathetic Nerve Activity
Hide Description [Not Specified]
Time Frame Measured at 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chlorthalidone Alone Chlorthalidone Plus Spironolactone Chlorthalidone Plus Irbesartan Spironolactone Chlorthalidone Irbesartan
Hide Arm/Group Description:
Chlorthalidone: 12.5-25 mg taken orally, once daily

Chlorthalidone: 12.5-25 mg taken orally, once daily

Spironolactone: 50-75 mg taken orally, once daily

Chlorthalidone: 12.5-25 mg taken orally, once daily

Irbesartan: 150 mg taken orally, once daily

Spironolactone 25-50 mg taken orally daily
Chlorthalidone 12.5-25 mg taken orally
Irbesartan 150 mg taken orally once a day
Overall Number of Participants Analyzed 17 17 17 18 18 7
Mean (Standard Deviation)
Unit of Measure: bursts/min
49  (4) 42  (3) 52  (2) 37  (2) 45  (3) 46  (4)
2.Primary Outcome
Title 24-hour Ambulatory Blood Pressure
Hide Description [Not Specified]
Time Frame Measured at 6 months
Outcome Measure Data Not Reported
3.Primary Outcome
Title Insulin Sensitivity
Hide Description [Not Specified]
Time Frame Measured at 6 months
Outcome Measure Data Not Reported
4.Primary Outcome
Title Forearm Blood Flow
Hide Description [Not Specified]
Time Frame Measured at 6 months
Outcome Measure Data Not Reported
5.Primary Outcome
Title Baroreflex Sensitivity
Hide Description [Not Specified]
Time Frame Measured at 6 months
Outcome Measure Data Not Reported
6.Primary Outcome
Title C-reactive Protein
Hide Description [Not Specified]
Time Frame Measured at 6 months
Outcome Measure Data Not Reported
7.Primary Outcome
Title Inflammatory Cytokines
Hide Description [Not Specified]
Time Frame Measured at 6 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Electrolytes
Hide Description [Not Specified]
Time Frame Measured at 6 months
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Body Weight
Hide Description [Not Specified]
Time Frame Measured at 6 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chlorthalidone Alone Chlorthalidone Plus Spironolactone Chlorthalidone Plus Irbesartan Irbesartan Chlorthalidone Spironolactone
Hide Arm/Group Description Chlorthalidone: 12.5-25 mg taken orally, once daily

Chlorthalidone: 12.5-25 mg taken orally, once daily

Spironolactone: 50-75 mg taken orally, once daily

Chlorthalidone: 12.5-25 mg taken orally, once daily

Irbesartan: 150 mg taken orally, once daily

Drug: Irbesartan 150 mg taken orally, once daily Chlorthalidone 12.5-25 mg taken orally daily Spironolactone 25-75 mg taken orally daily
All-Cause Mortality
Chlorthalidone Alone Chlorthalidone Plus Spironolactone Chlorthalidone Plus Irbesartan Irbesartan Chlorthalidone Spironolactone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Chlorthalidone Alone Chlorthalidone Plus Spironolactone Chlorthalidone Plus Irbesartan Irbesartan Chlorthalidone Spironolactone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%)   0/17 (0.00%)   0/7 (0.00%)   0/23 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chlorthalidone Alone Chlorthalidone Plus Spironolactone Chlorthalidone Plus Irbesartan Irbesartan Chlorthalidone Spironolactone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%)   0/17 (0.00%)   0/7 (0.00%)   0/23 (0.00%)   0/23 (0.00%) 
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
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