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NCT03962296
A Multicenter, Randomized, Double-blind Non-inferiority Trial to Evaluate the Efficacy and Safety of Entelon®
Phase 4 trial testing Vitis vinifera extract in Diabetic Retinopathy in 153 participants. Completed in 26 January 2015.
26 January 2015
Quick facts
| Lead sponsor | Hanyang University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 153 |
| Start date | 21 November 2012 |
| Primary completion | 26 January 2015 |
| Estimated completion | 26 January 2015 |
Drugs / interventions tested
- Vitis vinifera extract — full drug profile →
- Calcium Dobesilate (CALCIUM DOBESILATE) — full drug profile →
- Placebo
Conditions studied
- Diabetic Retinopathy — all drugs for Diabetic Retinopathy →
Sponsor
Hanyang University
Who can join
Adults 40 to 80, any sex, with Diabetic Retinopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This was a multicentre, randomised, double-blind controlled study that compared the efficacy and safety of V. vinifera extract, calcium dobesilate (CD), and placebo in subjects with DME. Patients made 6 clinic visits, namely the screening visit; baseline visit (T0); and follow-up visits at 3 (T3), 6 (T6), 9 (T9), and 12 (T12) months.
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 NCT03962296
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Hanyang University 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 NCT03962296 (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 Hanyang University
- Last refreshed: 24 May 2019
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/NCT03962296.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing