|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT00825266 |
|
Date of registration:
|
16/01/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Insulin Resistance in Pulmonary Arterial Hypertension
|
|
Scientific title:
|
The Effect of Bosentan and Pioglitazone on Insulin Resistance in Pulmonary Arterial Hypertension |
|
Date of first enrolment:
|
September 2008 |
|
Target sample size:
|
2 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT00825266 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Roham T. Zamanian |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Stanford University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
Patients with Pulmonary Arterial Hypertension (PAH) must be stable on therapy for at least
3 months prior to enrollment in the trial. We will include patients with idiopathic PAH and
Familial PAH as well as PAH associated with collagen vascular disease or drug or toxin
exposure. With the exception of PAH, subjects must be free of major medical illnesses,
including diabetes mellitus (must have fasting plasma glucose < 126 mg/dL and taking no
anti-hyperglycemic agent), malignancy or significant hepatic or renal disease. Subjects may
be hypertensive and on anti-hypertensive medications as long as blood pressure is < 150/100
mm Hg. Subjects may also be dyslipidemic and/or taking drugs to improve abnormalities of
lipid metabolism, but they will be excluded if they are taking medications known to alter
insulin sensitivity, including glucocorticoids, niacin, anti-retrovirals,
thiazolidinediones, or metformin. Use of oral contraceptives or estrogen and/or
progesterone replacement therapy is permitted. Weight must be stable and the subjects agree
not to change their eating habits or exercise regimen during the study period. There will
be no restrictions with regard to race or socioeconomic status, and the racial/ethnic
composition of the study population will be reflective of the communities surrounding the
Stanford University Medical Center.
Exclusion Criteria:
* Vulnerable subject status.
- Concurrent Endothelin-1 antagonist therapy
- Concurrent Thiazolidinedione therapy
- New York Heart Class III or IV
- PAH related to other etiologies.
- Diabetes Mellitus with Fasting Glucose Levels > 126 mg/dL
- Allergy or hypersensitivity to pioglitazone or bosentan administration.
- Current treatment with statin therapy.
- Initiation of PAH therapy (prostacyclin analogues, phosphodiesterase-5 inhibitors)
within three months of enrollment.
- Inability or unwillingness to avoid systemic steroid containing medications for four
months. Inhaled steroid use is acceptable.
- Current or recent use or planned treatment with: glyburide, cyclosporine, nilotinib,
nisoldipine, ranolazine, thioridazine
- Hepatic transaminases > 2x the upper limit of normal at the center at screening.
- Current or recent (< 6 months) chronic heavy alcohol consumption.
- Current use of another investigational drug (non-FDA approved) for PAH.
- Lung transplant recipients.
- History of myositis.
- Renal failure (Cr 2.0).
- Hospitalized or acutely ill.
- Chronic liver disease (cirrhosis, chronic hepatitis, etc.).
- Abnormalities of the arm or hand or radical mastectomy (preventing brachial artery
ultrasound).
- Pregnant or lactating women.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Hypertension, Pulmonary
|
|
Intervention(s)
|
|
Drug: Pioglitazone
|
|
Drug: bosentan
|
|
Primary Outcome(s)
|
|
Insulin Resistance Profile Change - Triglyceride:HDL Cholesterol Ratio
[Time Frame: baseline and 16 weeks]
|
|
Secondary Outcome(s)
|
|
6 Minute Walk Test
[Time Frame: Baseline and 16 weeks]
|
|
NYHA (New York Heart Association Classification) Changes
[Time Frame: Baseline and 16 weeks]
|
|
Secondary ID(s)
|
|
IRB#7432
|
|
SU-09052008-1295
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|