Last reviewed · How we verify
NCT00445107: STAR
SINGULAIR (R) as Complementary Therapy to Fixed Association Regimen (0476-363)
Phase 3 trial testing MK0476, montelukast sodium / Duration of Treatment: 8 Weeks in Asthma in 198 participants. Completed in 17 May 2006.
1 May 2006
Quick facts
| Lead sponsor | Organon and Co |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 198 |
| Start date | 1 November 2005 |
| Primary completion | 1 May 2006 |
| Estimated completion | 17 May 2006 |
Drugs / interventions tested
- MK0476, montelukast sodium / Duration of Treatment: 8 Weeks — full drug profile →
Conditions studied
- Asthma — all drugs for Asthma →
Sponsor
Organon and Co — full company profile →
Who can join
Adults 15 to 80, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess the treatment effect of montelukast 10mg on the primary endpoint of Asthma Control Questionnaire(ACQ), over a 8-week period, in persistent asthma patients with or without allergic rhinitis.
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 NCT00445107
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Organon and Co trials
Trials by the same sponsor.
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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 NCT00445107 (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 Organon and Co
- Last refreshed: 15 August 2024
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/NCT00445107.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing