BAY 63 2521 is a stimulator of the soluble guanylate cyclase (sGC) and is intended for the treatment of cardiovascular diseases, especially pulmonary hypertension (PH).To assess the longterm safety and tolerability of oral BAY 63-2521 in patients…
ID
Source
Brief title
Condition
- Heart failures
- Pulmonary vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints are safety and tolerability of a long-term treatment with BAY
63-2521.
Secondary outcome
Secundary endpoints are:
- Change from baseline in 6 MWD test
- Change from baseline in NT-pro BNP
- Change from baseline in WHO functional class
- Time To Clinical Worsening
- Change from baseline in Borg Dyspnoea Score (measured at the end of the 6MWD
Test)
- Change from baseline in EQ-5D questionnaire
- Change from baseline in LPH questionnaire
- Change in use of healthcare resources
Background summary
Chronic Thromboembolic Pulmonary Hypertension (CTEPH) is a severe disease with
a high mortality. Although pulmonary endarterectomy (PEA) has been proven to be
a very effective treatment for CTEPH it cannot be performed in a substantial
proportion of patients. Therefore, there is a high need for medical treatments
for CTEPH patients that are inoperable or who have a persistent pulmonary
hypertension after they underwent PEA.
Although the experiences with BAY 63-2521 with respect to the treatment of
CTEPH are limited, in the light of the severity of the underlying disease it is
justified to offer all patients who participated in the CHEST-1 trial a
long-term treatment with BAY 63-2521 (until commercially available).
Study objective
BAY 63 2521 is a stimulator of the soluble guanylate cyclase (sGC) and is
intended for the treatment of cardiovascular diseases, especially pulmonary
hypertension (PH).
To assess the longterm safety and tolerability of oral BAY 63-2521 in patients
with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or
recurrent or persisting pulmonary hypertension after surgical treatment.
Study design
Multicenter, multinational, openlabel, 1 arm, reserach in patients with CTEPH.
Intervention
All patients will receive oral BAY 63-2521 between 1 mg and 2.5 mg tid
according to an individual dose titration scheme.
Study burden and risks
The treatment period is set up as follow:
1. Treatment Phase
a. Titration phase: 8 weeks
b. Main-study phase: Duration until BAY 63-2521 receives official approval and
will be commercially available.
2. Safety follow up phase: 30 days
Incase patients participate until day 84 + the safety follow-up period:
7 hospital visits, 1 time hospitalisation for day and night, study medication
tid, possible side-effectd due to study medication, blood pressure (15x), heart
rate (15x), WHO functional class (4x), 6 MWD (4x), Borg CR10 Scale (4X), lab
blood sampling (4x), PK blood sampling (2x), ECG (6x), EQ-5D questionairre
(1x), LPH questionairre (1x).
From day 84, every 3 months the following procedured will be repeated:
Study medication tid, possible side-effects due to study medication, physical
examination, blood pressure, heart rate, blood gas analysis, WHO functional
class , 6 MWD, Borg CR10 Scale, lab blood sampling, PK blood sampling, ECG,
EQ-5D questionairre (1x) & LPH questionairre.
Energieweg 1
3641 RT Amsterdam
NL
Energieweg 1
3641 RT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
1) Signed and dated informed consent
2) Patients who have completed 16 weeks of treatment in the CHEST-1 trial.
Exclusion criteria
See page 13 of the protocol _ Paragraph 4.2.2
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 | EUCTR2008-003539-19-NL |
| ClinicalTrials.gov | NCT00910429 |
| CCMO | NL25451.029.08 |