BAY 63 2521 is a direct 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 the treatment of…
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 12 weeks.
Secondary outcome
Secondary efficacy endpoints are:
- Change from Baseline in Pulmonary Vascular Resistance (PVR) after 12 weeks
- Change from baseline in NT-pro BNP after 12 weeks
- Change from baseline in WHO functional class after 12 weeks
- Time To Clinical Worsening
- Change from baseline in Borg CR 10 Scale (measured at the end of the 6MWD
Test) after 12 weeks
- Change from baseline in EQ-5D questionnaire after 12 weeks
- Change from baseline in LPH questionnaire after 12 weeks
- Change in use of healthcare resources after 12 weeks
Safety Variables:
- Treatment emergent adverse events
- Treatment emergent serious adverse events
- Laboratory parameters
- ECG
- Heart rate
- Blood pressure
- Blood gases
Background summary
Pulmonary Arterial Hypertension (PAH) is a severe disease with a high
mortality. Although several drugs have been approved for the treatment of PAH
in the recent past, there is still a high medical need for new treatments.
Study objective
BAY 63 2521 is a direct 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 the treatment of naïve
patients and patients pretreated with an Endothelin Receptor Antagonist or a
Prostacycline Analogue with symptomatic Pulmonary Arterial Hypertension (PAH).
Study design
Randomized, double-blind, placebo-controlled, multi-centre, multi-national
study to evaluate the efficacy and safety of oral BAY 63-2521 in patients with
symptomatic PAH
Intervention
A three arm study (4:2:1)
1) 264 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) 132 patients will receive placebo tablets tid
3) 66 patients will be up-titrated to 1.5 mg BAY 63 2521 tid
Study burden and risks
The treatment period is set up as follow:
1. Pre-treatment phase: approximately 2 weeks
2. Treatment phase: 12 weeks
a. Titration phase: 8 weeks
b. Main phase 4 weeks
3. Safety Follow Up phase: 30 days
Incase the patient participates the entire treatment period:
8 hospital visits, 1 x hospitalisation for 1 day/night & 2 x hospitalisation
for 1 day (and possibly a night), study medication tid, possible side-effects
due to the study medication, physical examination (3x), blood pressure (16x),
heart rate (16x), lung function test (1x), blood gas analysis (3x), WHO
functional class (6x), 6MWD test (7x), Borg CR 10 Scale (7x), invasive
haemodynamic measurement (2x), lab blood sampling (15x), PK blood sampling
(6x), ECG (42x; each ECG is performed 3 times with 1 minute interval),
pregnancy test if applicable (3x) EQ-5D questionnaire (3x), LPH questionnaire
(3x) & Pharmacogenetic (1x)
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 symptomatic PAH (Group I / Venice Clinical Classification of PH), a 6MWD test between 150 m and 450 m, a pulmonary vascular resistance (PVR) >300 dyn*sec*cm-5 and a mean pulmonary artery pressure >25 mmHg
4) Treatment naïve patients (with respect to PAH specific medication) and patients pre-treated with an Endothelin Receptor Antagonist or a Prostacycline Analoguea.
Exclusion criteria
See page 18 - 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 | EUCTR2008-003482-68-NL |
| ClinicalTrials.gov | NCT00810693 |
| CCMO | NL25452.029.08 |