CLINICAL TRIALS PROFILE FOR ADEMPAS
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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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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