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NCT00197093
A Placebo Controlled, Double-Blind, Randomised Study Investigating the Safety, Tolerability and Pharmacokinetics of Ascending Multiple Oral Doses of SB-773812 in Male and Female Schizophrenic Patients for up to 28 Days
Phase 1 trial testing SB773812 in Schizophrenia in 60 participants. Completed.
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 September 2004 |
Drugs / interventions tested
- SB773812 — full drug profile →
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 18 to 55, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- Safety and Tolerability of 773812 during 28 days of dosing. Pharmacokinetics of 773812 after repeat dosing.
Sponsor's own description
This study is a placebo-controlled study to assess the safety and tolerability of a novel antipsychotic medication, (773812) when given to schizophrenic patients for twenty-eight days. Assessments include blood sampling to determine drug concentrations, psychiatric assessments while under treatment, and movement assessments to evaluate potential side effects.
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 NCT00197093
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SB773812
Trials testing the same drug.
- NCT00411866 — Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812 · Phase 1 · completed
- NCT00269035 — SPECT Study With SB-773812 In Schizophrenic Patients · Phase 1 · completed
Other recruiting trials for Schizophrenia
Currently open trials in the same condition.
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- NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
- NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
- NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
- NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
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- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
- NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
- NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting
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 NCT00197093 (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 GlaxoSmithKline
- Last refreshed: 15 May 2009
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/NCT00197093.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing