Trial Outcomes & Findings for Insulin Resistance in Pulmonary Arterial Hypertension (NCT NCT00825266)

Results Overview

insulin resistance measured -triglyceride: HDL cholesterol ratio measures at 16 weeks compared with baseline.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

baseline and 16 weeks

Results posted on

2017-03-31

Participant Flow

Participant milestones

Participant milestones
Measure	Bosentan 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 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 Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Insulin Resistance in Pulmonary Arterial Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bosentan n=1 Participants 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 n=1 Participants 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 n=2 Participants Total of all reporting groups
Age, Continuous	61 years n=5 Participants	51 years n=7 Participants	56 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 16 weeks

insulin resistance measured -triglyceride: HDL cholesterol ratio measures at 16 weeks compared with baseline.

Outcome measures

Outcome measures
Measure	Bosentan n=1 Participants 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 n=1 Participants 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.
Insulin Resistance Profile Change - Triglyceride:HDL Cholesterol Ratio	-0.22 ratio	-1.96 ratio

SECONDARY outcome

Timeframe: Baseline and 16 weeks

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.

Outcome measures

Outcome measures
Measure	Bosentan n=1 Participants 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 n=1 Participants 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.
6 Minute Walk Test	-71 meters	-23 meters

SECONDARY outcome

Timeframe: Baseline and 16 weeks

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}

Outcome measures

Outcome measures
Measure	Bosentan n=1 Participants 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 n=1 Participants 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.
NYHA (New York Heart Association Classification) Changes	0 NYHA class	0 NYHA class

Adverse Events

Bosentan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pioglitazone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roham Zamanian

Stanford University

Phone: 650-725-5495

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place