CLINICAL TRIALS PROFILE FOR ADEMPAS

All Clinical Trials for adempas

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02024386 ↗	Efficacy Study of Riociguat and Its Effects on Exercise Performance and Pulmonary Artery Pressure at High Altitude	Completed	Richard Moon	Phase 4	2014-01-01	During ascent to high altitude there is a physiologic response to hypoxia that results in an elevated pulmonary arterial pressure associated with decreased exercise performance, altitude-induced pulmonary hypertension, and high altitude pulmonary edema (HAPE). Riociguat is a novel agent from Bayer Pharmaceuticals that has already demonstrated effectiveness in the treatment of pulmonary hypertension, and it may prove to be beneficial in cases of altitude-induced pulmonary hypertension or HAPE. This research study, composed of 20 healthy volunteers ages 18-40 years, will attempt to mimic the decreased oxygen supply and elevated pulmonary artery pressures found in conditions of high altitude, allowing observation of the effects of riociguat and exercise on pulmonary arterial pressure, arterial oxygenation, and exercise performance. Prior to entering the hypobaric chamber, subjects will have radial arterial lines and pulmonary artery catheters placed to obtain arterial and pulmonary artery pressure measurements. Subjects will then enter the hypobaric chamber and perform exercise tolerance tests at a simulated altitude of 15,000 feet on an electrically braked ergometer (exercise bike) before and after administration of riociguat. If, after administration of riociguat and exposure to a simulated altitude of 15,000 feet, the exercise performance is improved and observed pulmonary artery pressures are lower than those measurements seen prior to administration of riociguat, this could lead to development of a prophylactic and/or treatment strategy for HAPE and high-altitude pulmonary hypertension. Statistical analysis will compare the variables of pulmonary artery pressure, radial arterial pressure, ventilation rate, cardiac output, PaO2, and work rate at exhaustion before and after administration of the drug riociguat. The investigator's hypothesis is that riociguat will decrease pulmonary artery pressure and improve gas exchange and exercise performance at altitude.
NCT02092818 ↗	EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension	Completed	Bayer		2014-05-31	In accordance with the regulatory guidance this registry has been designed to collect information about the long-term safety of Adempas in real clinical practice outside the regulated environment of a controlled clinical study.
NCT02159326 ↗	Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women	Completed	Bayer	Phase 1	2014-06-01	Physicians might be concerned that Adempas may have a metabolic interaction with oral contraceptives (OC) that could decrease the contraceptive efficacy of the OC. The information regarding lack of potential pharmacokinetic interaction has been communicated; there is a need for more re-assurance and further data that there is no interaction between Adempas and OCs. A drug-drug interaction study of riociguat with an OC such as Microgynon in the least vulnerable population for these purposes, i.e. healthy postmenopausal women, is considered adequate to inform about safe use of Adempas with OCs.
NCT02545465 ↗	A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical Practice	Completed	Bayer		2015-09-15	The aim of this study is to understand the treatment patterns in patients with Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) during a switch of treatment to Adempas in real-life clinical practice. In addition, this study will describe patient demographics and reason for switching
NCT02633397 ↗	A Multi-Center Study of Riociguat in Patients With Sickle Cell Diseases	Recruiting	Gregory J. Kato, MD	Phase 2	2017-04-11	The proposed study is a Phase 2 multi-center, randomized, double-blind, placebo-controlled, parallel groups study aimed to evaluate the safety, tolerability and the efficacy of riociguat compared with placebo in patients with sickle cell disease (SCD).
NCT02633397 ↗	A Multi-Center Study of Riociguat in Patients With Sickle Cell Diseases	Recruiting	Mark Gladwin	Phase 2	2017-04-11	The proposed study is a Phase 2 multi-center, randomized, double-blind, placebo-controlled, parallel groups study aimed to evaluate the safety, tolerability and the efficacy of riociguat compared with placebo in patients with sickle cell disease (SCD).

Clinical Trial Conditions for adempas

Condition Name

Condition Name for adempas
Intervention	Trials
Hypertension, Pulmonary	5
Pulmonary Arterial Hypertension	3
Chronic Thromboembolic Pulmonary Hypertension	2
CTEPH	2

Condition MeSH

Condition MeSH for adempas
Intervention	Trials
Hypertension	7
Hypertension, Pulmonary	7
Pulmonary Arterial Hypertension	5
Familial Primary Pulmonary Hypertension	3

Clinical Trial Locations for adempas

Trials by Country

Trials by Country for adempas
Location	Trials
United States	27
Germany	3
Italy	2
France	2
Austria	2

Trials by US State

Trials by US State for adempas
Location	Trials
North Carolina	3
Pennsylvania	2
New York	2
District of Columbia	2
California	2

Clinical Trial Progress for adempas

Clinical Trial Phase

Clinical Trial Phase for adempas
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 2	6

Clinical Trial Status

Clinical Trial Status for adempas
Clinical Trial Phase	Trials
Completed	8
Recruiting	6
Not yet recruiting	3

Clinical Trial Sponsors for adempas

Sponsor Name

Sponsor Name for adempas
Sponsor	Trials
Bayer	6
Medical University of Vienna	2
Actelion	2

Sponsor Type

Sponsor Type for adempas
Sponsor	Trials
Other	17
Industry	9