Primary: to assess the longterm safety and tolerability of ambrisentan 5mg in subjects with inoperable CTEPH. Secondary: to collect supportive efficacy data.
ID
Source
Brief title
Condition
- Pulmonary vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Adverse events.
Secondary outcome
6 minute walk test, WHO functional class, Borg CR10 scale, clinical worsening
of CTEPH, co-medication, NT-proBNP, SF-36 questionnaire.
Background summary
Chronic thromboembolic pulmonary hypertension (CTEPH) is a life-threatening
condition characterized by thrombus organization, stenosis of pulmonary artery,
and subsequent vascular remodeling in small unobstructed vessels, resulting in
increased pulmonary vascular resistance, progressive pulmonary hypertension
(PH) and right heart failure. CTEPH is associated with considerable morbidity
and mortality.
The preferred treatment for CTEPH is surgical disobliteration of the arteries
by pulmonary endarterectomy. The perioperative mortality is 5 to 10%. There are
significant improvements in hemodynamics. However for some patients surgery is
not an option. Management of these patients was previously supportive.
Disease-modifying therapies used in other forms of pulmonary arterial
hypertension have been utilized. There are no licensed treatments for CTEPH.
Ambrisentan is a selective endotheline receptor antagonist licensed for the
treatment of WHO FC II and III PH. Given that the histopathologic changes seen
in CTEPH, the evidence that endotheline-1 levels are raised, and the clinical
evidence (mainly uncontrolled) that a number of licensed PH treatments show
efficacy in CTEPH, it is hypothesised that ambrisentan may provide benefit to
patients with inoperable CTEPH.
This is an open-label extension study of the placebo controlled phase III study
with ambrisentan in inoperable patients with CTEPH (AMB115811).
Study objective
Primary: to assess the longterm safety and tolerability of ambrisentan 5mg in
subjects with inoperable CTEPH.
Secondary: to collect supportive efficacy data.
Study design
Open label, long term extension to study AMB115811. Ambrisentan 5 mg daily.
All subjects may continue in the extension study until one of the following
conditions is met:
* The product is approved locally and made commercially available for use in
inoperable CTEPH patients;
* Development for use in the CTEPH population is discontinued or product is not
approved by the local regulatory authorities
* The investigator decides to discontinue the subject or subject decides to
discontinue from the study.
Intervention
Treatment with ambrisentan.
Study burden and risks
Risk: Adverse effects of study medication.
Burden:
Monthly visits with blood draw (approx. 10 ml/occasion).
Every 3 months: Urine test, pregnancy test, physical examination, 6 minute walk
test.
ECG every 6 months.
SF-36 questionnaire every 3 months during 1st 18 months.
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Listed location countries
Age
Inclusion criteria
* Male and female patients with inoperable CTEPH, who have completed the week 16 visit of AMB115811 or who prematurely withdrew for whatever reason. Capable of giving informed consent.
Exclusion criteria
* Pregnancy or breastfeeding. Non compliance with contraceptive measures from AMB115811.
* Subjects who are to enter another clinical trial or be treated with another investigational product after exiting Study AMB115811.
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 | EUCTR2012-001642-17-NL |
| CCMO | NL45342.029.13 |
| Other | www.clinicaltrials.gov; registratienummer n.n.b. |