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NCT01570829
Multicentric Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Safety and Efficacy of New Dosage Schedule for Dietressa Drug in Treatment of Obese Patients
Phase 3 trial testing Dietressa in Obesity in 331 participants. Completed in 1 June 2013.
1 June 2013
Quick facts
| Lead sponsor | Materia Medica Holding |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 331 |
| Start date | 1 December 2011 |
| Primary completion | 1 June 2013 |
| Estimated completion | 1 June 2013 |
| Sites | 17 locations across Russia |
Drugs / interventions tested
- Dietressa — full drug profile →
- Placebo
Conditions studied
- Obesity — all drugs for Obesity →
Sponsor
Materia Medica Holding — full company profile →
Who can join
Adults 18 to 65, any sex, with Obesity. 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.
-
Percentage of Patients With at Least 5% Weight Loss.
Time frame: 24 weeks
Based on medical records. -
Average Absolute Weight Change
Time frame: On baseline and after 24 weeks
Based on medical records. -
Average Relative Weight Change
Time frame: On baseline and after 24 weeks
Based on medical records.
Sponsor's own description
* To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in treatment of obese patients (BMI 35,0-39,9 kg/m2). * To assess clinical efficacy of Dietressa in the dose of 6 tablets daily after 24 weeks of therapy in reducing body weight in obese patients (BMI 35,0-39,9 kg/m2).
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 NCT01570829
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Materia Medica Holding 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 NCT01570829 (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 Materia Medica Holding
- Last refreshed: 25 August 2021
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/NCT01570829.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing