Primary: To assess the effect of UT-15C sustained release (SR) on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 12) in subjects with PAH who are not currently receiving ERA, PDE-5…
ID
Source
Brief title
Condition
- Pulmonary vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the change in the distance traversed in the
Six-Minute Walk Test at Week 12 over placebo in subjects with PAH.
Secondary outcome
Borg Dyspnea Score
Combined Walk and Borg Dyspnea Score
Clinical Worsening
Dyspnea-Fatigue Index
WHO Functional Class
Symptoms of PAH
Background summary
Remodulin (treprostinil sodium) is an effective agent given by subcutaneous or
intravenous delivery. UT-15C is a diethanolamine salt of treprostinil and is
being investigated as a solid-dose oral compound. An oral product is easier to
use and at the moment only a few oral medicines are on the market for this
disease.
The primary hypothesis is that UT-15C SR will increase the distance traversed
in the Six-Minute Walk Test at Week 12 over placebo in subjects with PAH.
Study objective
Primary: To assess the effect of UT-15C sustained release (SR) on exercise
capacity compared to placebo (as measured by the change in 6-Minute Walk
distance from Baseline to Week 12) in subjects with PAH who are not currently
receiving ERA, PDE-5 inhibitor, prostacyclin therapy, or any combination. The
change in 6-Minute Walk distance will be evaluated primarily for subjects with
access to 0.25 mg tablets at the time of randomization, and secondarily for the
overall population.
Secondary:
To assess the effect of UT-15C SR on the following:
* Combined Walk Distance/Borg Dyspnea Score
* Clinical Worsening*
* Borg Dyspnea Score
* Dyspnea-Fatigue Index
* World Health Organization (WHO) Functional Class
* Symptoms of PAH
* Safety (adverse events, clinical laboratory parameters, electrocardiogram
findings)
*Definition of clinical worsening requires one of the following:
1. Death (all causes excluding accident)
2. Transplantation or atrial septostomy
3. Clinical deterioration as defined by:
a. Hospitalization as a result of PAH, or
b. >= 20% decrease in 6-Minute Walk distance from Baseline (or too ill to walk)
and a decrease in WHO Functional Class
And
c. Initiation of new PAH specific therapy (i.e., endothelin receptor
antagonist, phosphodiesterase-5 inhibitor, prostacyclin).
Study design
Multi-center, randomized, double-blind, placebo-controlled, 12-week study in
subjects with PAH not currently receiving therapy (ERA, PDE-5 inhibitor, or
prostacyclin) for the treatment of PAH.
Intervention
Each patient starts with one tablet studymedication or placebo twice daily of
0,25 mg.
This dose may be increased every three days with an additional 0,25 - 0,50 mg
twice daily. Subjects unable to tolerate the 0.25 mg dose or subjects requiring
an intermediate dose may utilize the 0.125 mg tablet.
Study burden and risks
Subjects will be assessed during Screening and Baseline Phases to determine
eligibility for the study. Once enrolled in the study following the Baseline
visit, four Treatment Phase visits to the clinic will be required at 4 weeks, 8
weeks, 11 weeks, and 12 weeks after randomization.
The treatment will start with a 0,25 mg tablet twice daily (every 12 hours +/-
1 hour) with a possible dose increase every 3 days of an additional 0,25-0,50
mg twice daily. Subjects unable to tolerate the 0.25 mg dose or subjects
requiring an intermediate dose may utilize the 0.125 mg tablet.
The most common reported adverse events of UT-15C SR during previous studies
include headache, flushes, dizziness and nausea. Other adverse events that
might occur with UT-15C SR dosing are vomitting, low blood pressure and jaw
pain.
The riscs of the 6 minute walk test may lead to fatigue, fainting, anthralgia,
De risico*s verbonden aan de 6 minuten wandeltest kunnen mogelijk leiden tot
vermoeidheid, flauwvallen, muscle soreness, strain or injury.
55 T.W. Alexander Drive, PO Box 14186
Research Triangle Park, NC 27709
US
55 T.W. Alexander Drive, PO Box 14186
Research Triangle Park, NC 27709
US
Listed location countries
Age
Inclusion criteria
1. The subject is between the ages of 12 and 75 years of age at Screening.
2. The subject weighs a minimum of 40 kilograms with a Body Mass Index (BMI) less than 40kg/m2 at Screening.
3. The subject, if female, is physiologically incapable of childbearing or practicing an acceptable method of birth control. For women of childbearing potential, a negative serum pregnancy test will be required at Screening.
4. The subject has a diagnosis of symptomatic Idiopathic or Familial PAH (including PAH associated with appetite suppressant/toxin use), PAH associated with repaired congenital systemic-to-pulmonary shunts (repaired >= 5 years), PAH associated with Collagen Vascular Disease, or PAH associated with HIV.
5. The subject, if HIV positive, has a CD4 lymphocyte count >= 200 within 30 days of Baseline and is receiving current standard of care anti-retroviral or other effective medication for treatment of HIV.
6. The subject must have a Baseline 6-Minute Walk distance of between 200 and 400 meters, inclusive.
7. The subject may benefit from the introduction of therapy (e.g. a prostacyclin) as determined by their medical provider.
8. The subject must be optimally treated with conventional pulmonary hypertension therapy.
9. The subject will voluntarily give informed consent to participate in the study.
Exclusion criteria
1. The subject is pregnant or lactating.
2. The subject has previously received a prostacyclin, endothelin receptor antagonist, or phosphodiesterase-5 inhibitor within 30 days of Baseline.
3. The subject has had a new type of chronic therapy for pulmonary hypertension added within 14 days of Baseline.
4. The subject has had any PAH medication except for anticoagulants discontinued within 14 days of Baseline.
5. The subject has any disease associated with pulmonary arterial hypertension other than mentioned in the inclusion criteria.
6. The subject has a current diagnosis of uncontrolled sleep apnea.
7. The subject has chronic renal insufficiency.
8. The subject has anemia.
9. The subject has a history or current evidence of left-sided heart disease
10. The subject has significant parenchymal lung diseasea.
11. The subject has uncontrolled systemic hypertension.
12. The subject has any disease that is likely to limit ambulation.
13. The subject is participating, or has participated in another investigational drug or device study within 30 days prior to Screening.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-000801-50-NL |
| ClinicalTrials.gov | NCT00325403 |
| CCMO | NL15469.029.06 |