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Trial record 53 of 66 for:    "Lung Disease" | "Bosentan"

Insulin Resistance in Pulmonary Arterial Hypertension

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ClinicalTrials.gov Identifier: NCT00825266
Recruitment Status : Terminated (difficulty in finding eligible subjects)
First Posted : January 21, 2009
Results First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Roham T. Zamanian, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Hypertension, Pulmonary
Interventions Drug: bosentan
Drug: Pioglitazone
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bosentan Pioglitazone
Hide Arm/Group Description

Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.

bosentan: Bosentan 62.5 mg twice daily for 4 weeks, then 125mg BID for duration of study.

Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.

Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study.

Period Title: Overall Study
Started 1 1
Completed 1 1
Not Completed 0 0
Arm/Group Title Bosentan Pioglitazone Total
Hide Arm/Group Description

Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.

bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study.

Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.

Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study.

Total of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 2 participants
61
(61 to 61)
51
(51 to 51)
56
(51 to 61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
1
 100.0%
1
 100.0%
2
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 2 participants
1 1 2
1.Primary Outcome
Title Insulin Resistance Profile Change - Triglyceride:HDL Cholesterol Ratio
Hide Description insulin resistance measured -triglyceride: HDL cholesterol ratio measures at 16 weeks compared with baseline.
Time Frame baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bosentan Pioglitazone
Hide Arm/Group Description:

Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.

bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study.

Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.

Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study.

Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: ratio
-0.22 -1.96
2.Secondary Outcome
Title 6 Minute Walk Test
Hide Description 6 minute walk test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes.It assess the disease severity of the subject at 16 week compared to the baseline.
Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bosentan Pioglitazone
Hide Arm/Group Description:

Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.

bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study.

Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.

Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study.

Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: meters
-71 -23
3.Secondary Outcome
Title NYHA (New York Heart Association Classification) Changes
Hide Description

New York Heart Classification(NYHA) changes measured at 16 weeks compared with baseline.

NYHA Classification:

NYHA class I:no symptoms and no limitation in ordinary physical activity NYHA class II:Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity NYHA class III:Marked limitation in activity due to symptoms, even during less-than-ordinary activity, NYHA class IV:Severe limitations. Experiences symptoms even while at rest. {Higher NYHA class represent worse symptoms}

Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bosentan Pioglitazone
Hide Arm/Group Description:

Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.

bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study.

Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.

Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study.

Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: NYHA class
0 0
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bosentan Pioglitazone
Hide Arm/Group Description

Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.

bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study.

Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.

Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study.

All-Cause Mortality
Bosentan Pioglitazone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bosentan Pioglitazone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bosentan Pioglitazone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (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: Roham Zamanian
Organization: Stanford University
Phone: 650-725-5495
EMail: roham.zamanian@stanford.edu
Layout table for additonal information
Responsible Party: Roham T. Zamanian, Stanford University
ClinicalTrials.gov Identifier: NCT00825266     History of Changes
Other Study ID Numbers: SU-09052008-1295
IRB#7432
First Submitted: January 16, 2009
First Posted: January 21, 2009
Results First Submitted: November 21, 2016
Results First Posted: March 31, 2017
Last Update Posted: March 31, 2017