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Generated: February 20, 2019

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CLINICAL TRIALS PROFILE FOR ADEMPAS

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Clinical Trials for Adempas

Trial ID Title Status Sponsor Phase Summary
NCT02024386 Efficacy Study of Riociguat and Its Effects on Exercise Performance and Pulmonary Artery Pressure at High Altitude Completed Richard Moon Phase 4 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 Recruiting Bayer N/A 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 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 N/A 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 Active, not recruiting Gregory J. Kato, MD Phase 2 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 SCD.
NCT02744339 Pharmacodynamic Effects of Riociguat in Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction Recruiting Medical University of Vienna Phase 2 The primary objective of this study is to • Assess the pharmacodynamic profile of riociguat in subjects with symptomatic pulmonary hypertension and heart failure with preserved ejection fraction The secondary objectives of this study are to - Assess safety and tolerability of riociguat in this study population - Assess changes in dimensions of left and right ventricles and cardiac function parameters using cardiac magnetic resonance imaging
NCT02915835 Riociguat in Scleroderma Associated Digital Ulcers Recruiting Bayer Phase 2 The primary objective of this study is to provide preliminary data on the efficacy (digital ulcer net burden) and safety of riociguat administered 3 times daily (TID) in comparison to placebo in patients with scleroderma-associated digital ulcers
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Adempas

Condition Name

Condition Name for Adempas
Intervention Trials
Hypertension, Pulmonary 4
Chronic Thromboembolic Pulmonary Hypertension 2
Chronic Thromboembolic Disease (CTED) 1
Heart Failure With Normal Ejection Fraction 1
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Condition MeSH

Condition MeSH for Adempas
Intervention Trials
Hypertension, Pulmonary 6
Hypertension 4
Scleroderma, Systemic 1
Altitude Sickness 1
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Clinical Trial Locations for Adempas

Trials by Country

Trials by Country for Adempas
Location Trials
United States 8
Germany 2
Austria 2
France 1
Venezuela 1
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Trials by US State

Trials by US State for Adempas
Location Trials
Utah 1
Pennsylvania 1
New York 1
Michigan 1
District of Columbia 1
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Clinical Trial Progress for Adempas

Clinical Trial Phase

Clinical Trial Phase for Adempas
Clinical Trial Phase Trials
Phase 4 1
Phase 2 5
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Adempas
Clinical Trial Phase Trials
Recruiting 4
Completed 3
Not yet recruiting 2
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Clinical Trial Sponsors for Adempas

Sponsor Name

Sponsor Name for Adempas
Sponsor Trials
Bayer 5
Medical University of Vienna 2
Richard Moon 1
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Sponsor Type

Sponsor Type for Adempas
Sponsor Trials
Other 7
Industry 5
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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Mallinckrodt
Daiichi Sankyo
Chinese Patent Office
Boehringer Ingelheim
Moodys
Citi
McKinsey
Julphar

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