Drugs / Paliperidone ER
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT01662648 | Jun 2007 → Apr 2008 | schizophrenia | Janssen Pharmaceutica | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT01081769 Comparator | Feb 2010 → Feb 2013 | schizophrenia | Janssen-Cilag International NV | Completed | Met primary |
| Phase 4 | NCT00524043 Comparator | Sep 2007 → Nov 2008 | schizophrenia | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2014-06-04 | Janssen Research & Development, LLC | Regulatory INVEGA® receives European Commission approval to extend its adult indication for treatment of schizophrenia to include adolescents aged 15 years and older jnj.com ↗
Janssen-Cilag International NV announced today that the European Commission has approved an extension of the oral atypical antipsychotic INVEGA® (paliperidone ER) schizophrenia indication, to include adolescents aged 15 years and older. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2014-06-04 | Janssen Research & Development, LLC | INVEGA® receives European Commission approval to extend its adult indication for treatment of schizophrenia to include adolescents aged 15 years and older jnj.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Paliperidone ER | “Patients randomized to oral comparator arm will receive oral antipsychotics (haloperidol, paliperidone ER, risperidone, olanzapine, quetiapine or aripiprazole) as per...” NCT01081769 ↗ |
| Known as | Paliperidone extended-release (ER) | “Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion.” NCT01662648 ↗ |
| Route | Oral | “Oral paliperidone ER 1.5 mg or 6.0 mg tablets” NCT00524043 ↗ |