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 efficacy and safety of oral BAY 63 2521 in patients with inoperable…
ID
Source
Brief title
Condition
- Heart failures
- Pulmonary vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is change from baseline in 6 Minute Walking Distance
(6MWD) after 16 weeks.
Secondary outcome
Secondary efficacy endpoints are:
- Change from Baseline in Pulmonary Vascular Resistance (PVR) after 16 weeks
- Change from baseline in NT-pro BNP after 16 weeks
- Change from baseline in WHO functional class after 16 weeks
- Time To Clinical Worsening
- Change from baseline in Borg CR10 Score (measured at the end of the 6MWD
Test) after 16 weeks
- Change from baseline in EQ-5D questionnaire after 16 weeks
- Change from baseline in LPH questionnaire after 16 weeks
- Change in use of healthcare resources after 16 weeks
Safety Variables
- Treatment emergent adverse events
- Treatment emergent serious adverse events
- Laboratory parameters
- ECG
- Heart rate
- Blood pressure
- Blood gases
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.
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 efficacy and safety 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
Randomized, double-blind, placebo-controlled, multicentre, multi-national study
to evaluate the efficacy and safety of oral BAY 63-2521 in patients with CTEPH.
Intervention
A two arm study (2:1):
1) 180 patients will receive a BAY 63 2521 dose between 1 mg and 2.5 mg tid
determined based on an individual dose titration scheme
2) 90 patients will receive placebo tablets tid
Study burden and risks
The treatment period is set up as follow:
1. Pre-treatment phase: approximately 4 weeks
2. Treatmentphase: 16 weeks
a. Titration phase: 8 weeks
b. Main phase: 8 weeks
3. Safety Follow Up phase: 30 days
Incase the patient participates the entire treatment period:
9 hospital visits, 1 time hospitalisation for day and night & 2
hospitalisations for 1 day (and possibly for a night), study medication tid,
possible side-effects due to study medication, Physical examination (3x), blood
pressure (16x), heart rate(16x), lung function test (1x), blood gas analysis
(3x), WHO functional class (7x), 6 MWD (8x), Borg CR10 Scale (8X), invasive
heamodynamic measurement (2x), lab blood sampling (11x), PK blood sampling
(7x), ECG (11x), pregnancy test if applicable (3x), EQ-5D questionairre (3x),
LPH questionairre (3x).
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) 18 to 80 years of age at Visit 1
3) Male and female patients with CTEPH and a 6MWD Test between 150 m and 450 m either
defined as:
a) Inoperable due to the consideration of an experienced surgeon, with
pulmonary vascular resistance >300 dyn*sec*cm-5 measured at least 90 days after start of full anticoagulation and mean pulmonary artery
pressure >25 mmHg
b) With persisting or recurrent PH after Pulmonary Endarterectomy
4) Unspecific treatments which may also be used for the treatment of pulmonary
hypertension such as oral anticoagulants, diuretics, digitalis, calcium channel
blockers or oxygen supplementation are permitted. ;See page 15 - 17 of the protocol Paragraph 4.2.1
Exclusion criteria
See page 17 - 21 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 | EUCTR2007-000072-16-NL |
| ClinicalTrials.gov | NCT00855465 |
| CCMO | NL25450.029.08 |