WHO ICTRP trial
6-WEEK TRIAL OF THE EFFICACY AND SAFETY OF ASENAPINE COMPARED TO RISPERIDONE IN…
CTRI/2010/091/000423 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2010/091/000423 |
|---|---|
| Public title | 6-WEEK TRIAL OF THE EFFICACY AND SAFETY OF ASENAPINE COMPARED TO RISPERIDONE IN ADULT PATIENT WITH ACUTE EXACERBATION OF SCHIZOPHRENIA |
| Scientific title | AN OPEN LABEL, RANDOMIZED, PARALLEL GROUP, PROSPECTIVE, MULTICENTER CLINICAL TRIAL OF ASENAPINE TO EVALUATE ITS SAFETY AND EFFICACY IN ADULT PATIENTS WITH ACUTE EXACERBATION OF SCHIZOPHRENIA |
| Primary sponsor | Intas Pharmaceuticals Limited |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | India |
| Conditions | Health Condition 1: null- ACUTE EXACERBATION OF SCHIZOPHRENIA |
| Interventions | Intervention1: Asenapine: Asenapine 2.5 mg sublingual tablets will be started as one tablet twice daily. On visit 3 (Day 8±1), if significant control of schizophrenia is not achieved, the dose of study drugs will be doubled to two tablets… |
| Registration date | Jun 12, 2010 |
| Target size | 280 |
| Secondary IDs | CT/ASPN/SCHIZO/III/09 |
| Registry page | ctri.nic.in |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: