Last reviewed · How we verify
NCT03386851
Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder
trial in Schizophrenia in 1,030 participants. Completed in 25 May 2021.
25 May 2021
Quick facts
| Lead sponsor | Korea Otsuka Pharmaceutical Co., Ltd. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,030 |
| Start date | 13 December 2016 |
| Primary completion | 25 May 2021 |
| Estimated completion | 25 May 2021 |
| Sites | 1 location across South Korea |
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
- Bipolar 1 Disorder — all drugs for Bipolar 1 Disorder →
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd. — full company profile →
Who can join
19 and older, any sex, with Schizophrenia or Bipolar 1 Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Post-Marketing Surveillance (PMS) of Abilify Maintena® Injections in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: Ministry of Food and Drug Safety(MFDS) Notification).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03386851
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Korea Otsuka Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
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- NCT04189705 — A Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis · Phase 3 · completed
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- NCT03949894 — Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domI · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03386851 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Korea Otsuka Pharmaceutical Co., Ltd.
- Last refreshed: 14 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03386851.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing