Pulmonary hypertension associated with diastolic heart failure MedDRA version: 13.1 Level: LLT Classification code 10037405 Term: Pulmonary hypertension primary System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Riociguat
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive nam
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must fulfill all of the following criteria before being included in the study: 1.Age = 18 years 2.Invasive confirmation of PH associated with DHF documented by right heart catheter measurements of the following parameters: -PAPmean = 25 mmHg and - PCWP >15 mmHg 3. Transthoracic echocardiography - confirming preserved ejection fraction with LVEF>50% and - evidence for diastolic dysfunction: either o in patients with sinus rhythm: either abnormal relaxation (E/A wave ratio 2) or o in patients with atrial fibrillation: E-wave deceleration time I 5. Serum NT-proBNP >220 pg/ml 6.Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
Exclusion criteria: General exclusion criteria: 1.Previous assignment to treatment during this study 2.Participation in another clinical trial during the preceding 30 days. 3.Pregnant women, or breast feeding women, or women with childbearing potential not using a combination of condoms and a safe and highly effective contraception method (hormonal contraception with implants or combined oral contraceptives, certain intrauterine devices [IUDs]). 4.Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator. 5.Patients with a history of severe allergies or multiple drug allergies. 6.Known hypersensitivity to study drug or any of the excipients Medication/Treatment exclusion criteria: 1.Pre-Treatment within 30 days before randomization with: •intravenous (IV) inotropes or IV vasodilators •endothelin receptor antagonists (ERAs), PDE5 inhibitors or prostanoids. 2.Treatment within 7 days before randomization with NO donors (e.g. nitrates). 3.Requirement of treatment with prohibited drugs (see section 6.9) within 48 h after study drug intake. Pulmonary diseases exclusion criteria: 1.Bronchial asthma or COPD with Forced Expiratory Volume in one second (FEV1) 110 bpm 12. Uncontrolled arterial hypertension (Systolic blood pressure >180 mmHg and /or diastolic blood pressure >110 mmHg) or arterial hypertension not optimally managed according to current guidelines and requiring immediate antihypertensive treatment. Exclusion criteria related to disorders in organ function: 1.Clinically r
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the present study is to evaluate the acute hemodynamic effects, safety, and pharmacokinetics of Riociguat in patients with PH associated with diastolic heart failure.;Secondary Objective: ;Primary end point(s): The primary efficacy variable is the peak decrease from baseline in mean pulmonary arterial pressure (PAPmean). | — |
Countries
Austria, Czech Republic, Germany
Contacts
Public ContactCTP Team / Ref:"EU CTR"/ S102-R156
Bayer HealthCare AG
Outcome results
None listed