check_circleStudy Completed
Pulmonary Hypertension
Bayer Identifier:
15096
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parameters.
Trial purpose
Pulmonary Arterial Hypertension (PAH) is a severe progressive disease with a high mortality. Although several drugs are available for the treatment of PAH none offer a cure, therefore there is still a high medical need for new treatments.
Soluble guanylate cyclase (sGC) is one of the chemicals involved in the pathways controlling vascular tone, which is impaired in patients with PAH. This causes constriction and thickening of the blood vessels wall in the lungs and increase of blood pressure in the lungs. This can lead to the very debilitating symptoms of PAH such as tiredness, shortness of breath on exertion, collapse and often the inability of the patient to perform their daily life activities.
Inhalation of Nitric Oxide, which activates sGC is used to treat PAH, but its effect wears off as soon as inhalation stops. Direct stimulation of sGC using this new compound Riociguat may be a new approach for the treatment of PAH.
The phosphodiesterase 5 (PDE5)-inhibitor Sildenafil is one of licensed treatments for PAH. The Patent Plus is a double-blind, placebo-controlled safety study, designed to investigate the effect of Riociguat on blood pressure in patients with PAH when given in combination with Sildenafil.
Soluble guanylate cyclase (sGC) is one of the chemicals involved in the pathways controlling vascular tone, which is impaired in patients with PAH. This causes constriction and thickening of the blood vessels wall in the lungs and increase of blood pressure in the lungs. This can lead to the very debilitating symptoms of PAH such as tiredness, shortness of breath on exertion, collapse and often the inability of the patient to perform their daily life activities.
Inhalation of Nitric Oxide, which activates sGC is used to treat PAH, but its effect wears off as soon as inhalation stops. Direct stimulation of sGC using this new compound Riociguat may be a new approach for the treatment of PAH.
The phosphodiesterase 5 (PDE5)-inhibitor Sildenafil is one of licensed treatments for PAH. The Patent Plus is a double-blind, placebo-controlled safety study, designed to investigate the effect of Riociguat on blood pressure in patients with PAH when given in combination with Sildenafil.
Key Participants Requirements
Sex
BothAge
18 - 75 YearsTrial summary
Enrollment Goal
18Trial Dates
August 2010 - May 2013Phase
Phase 2Could I Receive a placebo
YesProducts
Adempas (Riociguat, BAY63-2521)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | Gießen, 35392, Germany | |
Terminated | Berlin, 13353, Germany | |
Completed | Hamburg, 20246, Germany | |
Completed | Köln, 50924, Germany | |
Completed | Dresden, 01307, Germany | |
Completed | Regensburg, 93042, Germany | |
Completed | Heidelberg, 69126, Germany | |
Terminated | Mönchengladbach, 41063, Germany | |
Terminated | Warszawa, 01-138, Poland | |
Completed | Bologna, 40138, Italy | |
Completed | Pavia, 27100, Italy | |
Completed | Vseobecna fakultni nemocnice | Praha 2, 12808, Czech Republic |
Terminated | Innsbruck, 6020, Austria | |
Terminated | Villach, 9500, Austria | |
Completed | Würzburg, 97074, Germany | |
Terminated | Hannover, 30625, Germany | |
Terminated | Clydebank, G81 4DY, United Kingdom | |
Completed | Papworth Hospital | Cambridge, CB23 3RE, United Kingdom |
Terminated | Providence, 02903, United States | |
Terminated | Columbus, 43221, United States | |
Completed | Barcelona, 08036, Spain | |
Terminated | Aurora, 80045, United States | |
Terminated | Christchurch, 8011, New Zealand | |
Terminated | Auckland, 1051, New Zealand | |
Terminated | Otwock, 05-400, Poland |
Primary Outcome
- Maximum change from baseline in supine systolic blood pressure (SBP) within 4 hours post-dose at visit 6 (week 12)date_rangeTime Frame:Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)enhanced_encryptionYesSafety Issue:
Secondary Outcome
- Maximum change from baseline in standing systolic blood pressure (SBP) within 4 hours post-dose at visit 6 (week 12)date_rangeTime Frame:Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)enhanced_encryptionYesSafety Issue:
- Maximum change from baseline in supine diastolic blood pressure (DBP) within 4 hours post-dose at visit 6 (week 12)date_rangeTime Frame:Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)enhanced_encryptionYesSafety Issue:
- Maximum change from baseline in standing diastolic blood pressure (DBP) within 4 hours post-dose at visit 6 (week 12)date_rangeTime Frame:Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)enhanced_encryptionYesSafety Issue:
- Maximum change from baseline in supine heart rate (HR) within 4 hours post-dose at visit 6 (week 12)date_rangeTime Frame:Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)enhanced_encryptionYesSafety Issue:
- Maximum change from baseline in standing heart rate (HR) within 4 hours post-dose at visit 6 (week 12)date_rangeTime Frame:Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)enhanced_encryptionYesSafety Issue:
- Area under effect curve (AUEC) of supine SBP within 4 hours post-dose at visit 6 (week 12)date_rangeTime Frame:Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)enhanced_encryptionYesSafety Issue:
- Area under effect curve (AUEC) of standing SBP within 4 hours post-dose at visit 6 (week 12)date_rangeTime Frame:Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)enhanced_encryptionYesSafety Issue:
- Area under effect curve (AUEC) of supine DBP within 4 hours post-dose at visit 6 (week 12)date_rangeTime Frame:Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)enhanced_encryptionYesSafety Issue:
- Area under effect curve (AUEC) of standing DBP within 4 hours post-dose at visit 6 (week 12)date_rangeTime Frame:Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)enhanced_encryptionYesSafety Issue:
- Area under effect curve (AUEC) of supine HR within 4 hours post-dose at visit 6 (week 12)date_rangeTime Frame:Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)enhanced_encryptionYesSafety Issue:
- Area under effect curve (AUEC) of standing HR within 4 hours post-dose at visit 6 (week 12)date_rangeTime Frame:Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)enhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2