WHO ICTRP trial
Safety and effect on central retinal thickness of BI 1026706 in patients with…
EUCTR2015-003529-33-DE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2015-003529-33-DE |
|---|---|
| Public title | Safety and effect on central retinal thickness of BI 1026706 in patients with diabetic macular edema |
| Scientific title | A randomized, double-masked, placebo-controlled exploratory study to evaluate pharmacodynamics, safety and tolerability of orally administered BI 1026706 for 12 weeks in patients with mild visual impairment due to center-involved diabetic macular edema (DME) |
| Primary sponsor | Boehringer Ingelheim Pharma GmbH & Co. KG |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Portugal;Hungary;Greece;Belgium;Spain;Germany;United Kingdom |
| Conditions | Patients with mild visual impairment due to center-involved diabetic macular edema (DME) MedDRA version: 20.0 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853 ;Therapeutic area: Diseases… |
| Interventions | Product Code: BI 1026706 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: not available Other descriptive name: BI 1026706 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical… |
| Registration date | Jan 20, 2016 |
| Target size | 125 |
| Secondary IDs | 1320.22 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: