Ignite Creation Date:
2024-05-05 @ 10:45 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01179334
Status:
COMPLETED
Last Update Posted:
2016-08-29
First Post:
2010-08-10
Brief Title:
Evaluation of the Pharmacodynamic Effect of the Combination of Sildenafil and Riociguat on Blood Pressure and Other Safety Parameters
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
An Interaction Study to Evaluate Changes in Blood Pressure Following 1 15 2 and 25 mg Riociguat Tid Dose Titration Compared to Placebo Treatment on the Background of Stable Sildenafil Pretreatment in Subjects With Symptomatic Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PATENT PLUS
Brief Summary:
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
Detailed Description:
Main objective Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parameters in patients with symptomatic PAH Secondary objectivesTo investigate the safety of the riociguatsildenafil combination and changes in 6-minute walk test World Health Organization WHO functional class N terminal pro-brain natriuretic peptide and variables obtained during right-heart catheterization after 12 weeks of treatment pharmacokinetics of riociguat and sildenafil
The study consists of one part In study Part 1 only subjects 18 on stable sildenafil treatment of 20 mg tid have been enrolled Study Part 2 will not start
The study consists of one part In study Part 1 only subjects 18 on stable sildenafil treatment of 20 mg tid have been enrolled Study Part 2 will not start
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-018863-40 | EUDRACT_NUMBER | None | None |