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NCT04589130: COR-WM
Evaluating Contrave for Weight Maintenance in Adults With BMI >= 27 Kg/m2, After 6 Month Behaviour Modification Program.
Phase 4 trial testing Contrave 8Mg-90Mg Extended-Release Tablet in Obesity in 89 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | St. Joseph's Healthcare Hamilton |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 89 |
| Start date | 1 February 2021 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 3 locations across Canada |
Drugs / interventions tested
- Contrave 8Mg-90Mg Extended-Release Tablet — full drug profile →
- Placebo
Conditions studied
- Obesity — all drugs for Obesity →
Sponsor
St. Joseph's Healthcare Hamilton — full company profile →
Who can join
18 and older, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Contrave (naltrexone HCl and bupropion HCl) extended-release tablet is an approved drug and indicated to be used with a low calorie diet and increased physical activity for chronic weight management in obese adults (BMI 30 Kg/m2 or greater) or overweight adults (BMI 27 Kg/m2 or greater) with at least one weight related condition such as hypertension or diabetes. Presently we do not have any evidence for the use of Contrave for weight maintenance. The purpose of this study is to demonstrate that in participants who have ≥ 5% weight loss following the completion of a behaviour modification program with meal replacements, Contrave combined with usual care (dietary and behaviour counselling) will significantly improve maintenance of weight loss and promote further weight loss, compared to placebo with usual care.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04589130
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other St. Joseph's Healthcare Hamilton 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 NCT04589130 (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 St. Joseph's Healthcare Hamilton
- Last refreshed: 3 August 2023
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/NCT04589130.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing