WHO ICTRP trial
Clinical trial investigating the effect of riociguat among patients with…
EUCTR2021-001633-40-DE · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2021-001633-40-DE |
|---|---|
| Public title | Clinical trial investigating the effect of riociguat among patients with slightly elevated blood pressure in lung vessels |
| Scientific title | Efficacy and safety of riociguat (MK-4836) in incipient pulmonary vascular disease as an indicator for early pulmonary arterial Hypertension Doubleblind, randomized, multicentre, multinational, placebo-controlled phase IIa study ESRA - ESRA |
| Primary sponsor | Thoraxklinik Heidelberg gGmbH |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Austria;Norway;United Kingdom;Italy;France;Switzerland;Germany |
| Conditions | early pulmonary vascular disease, defined as either a) mean pulmonary arterial pressure (mPAP) =25 mmHg with pulmonary vascular resistance (PVR) =2 to <3 WU and pulmonary arterial wedge pressure (PAWP) =15 mmHg or b) mPAP 21-<25 mmHg with… |
| Interventions | Product Name: Riociguat Product Code: MK-4836 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RIOCIGUAT CAS Number: 625115-55-1 Other descriptive name: BAY 63-2521 Concentration unit: mg milligram(s) Concentration type: equal… |
| Registration date | Jun 12, 2021 |
| Target size | 70 |
| Secondary IDs | ESRA;MK-4836-004 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: