WHO ICTRP trial
Randomized, double-blind, placebo-controlled, multi-centre, multi-national study…
NL-OMON35306 · Overview of Medical Research in the Netherlands (NL-OMON) · Not Recruiting
Key facts
| Trial ID | NL-OMON35306 |
|---|---|
| Public title | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). |
| Scientific title | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study |
| Primary sponsor | Bayer |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | 3 |
| Countries | Netherlands |
| Conditions | Pulmonary hypertension / increased blood pressure in the lungs;10019280;10037454;Pulmonary hypertension / increased blood pressure in the lungs |
| Interventions | A three arm study (4:2:1) 1) 264 patients will receive a BAY 63 2521 dose between 1 mg and 2.5 mg tid determined based on an individual dose titration scheme 2) 132 patients will receive placebo tablets tid 3) 66 patients will be… |
| Registration date | May 7, 2010 |
| Target size | 10 |
| Secondary IDs | 2008-003482-68;NCT00810693;NL25452.029.08 |
| Registry page | onderzoekmetmensen.nl |
At a glance
- No Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: