drugset / Trial / NCT00083668
Trial Evaluating Three Fixed Doses of Paliperidone Extended-Release (ER) Tablets and Olanzapine in the Treatment of Patients With Schizophrenia
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective of the double-blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of paliperidone ER (3, 9, and 15 mg/day) compared with placebo in adult patients with schizophrenia
Timeline
- Start
- 2004-04
- Primary completion
- —
- Completion
- 2005-05
Publications
- Results Davidson M, Emsley R, Kramer M, Ford L, Pan G, Lim P, Eerdekens M. Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): results of a 6-week, randomized, placebo-controlled study. Schizophr Res. 2007 Jul;93(1-3):117-30. doi: 10.1016/j.schres.2007.03.003. Epub 2007 Apr 26.
- Results Meltzer HY, Bobo WV, Nuamah IF, Lane R, Hough D, Kramer M, Eerdekens M. Efficacy and tolerability of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 6-week, placebo-controlled studies. J Clin Psychiatry. 2008 May;69(5):817-29. doi: 10.4088/jcp.v69n0515.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paliperidone | Unknown | 3 mg | Oral |
| Subject | Paliperidone | Unknown | 6 mg | Oral |
| Subject | Paliperidone | Unknown | 9 mg | Oral |
| Subject | Paliperidone | Unknown | 12 mg | Oral |
| Subject | Paliperidone | Unknown | 15 mg | Oral |