Trials / Terminated
TerminatedNCT00619229
Alprostadil in Maculopathy Study (AIMS)
Confirmatory, Prospective, Randomized, Double-blind, Placebo-controlled, Parallel Groups Study to Assess the Efficacy and Safety of Prostaglandin E1 in Subjects With Dry Age-related Macular Degeneration.
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- UCB Pharma · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
Evaluation of efficacy of alprostadil (prostaglandin E1) for treatment of patients suffering from dry age-related macula degeneration
Detailed description
Results of the planned interim analysis indicated that the number of originally planned patients were not sufficient to reach statistical significance in the primary end point. Instead of increasing the sample size accordingly, it was decided to terminate the study and plan future proceedings based on a careful analysis of the unblinded results.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Alprostadil (prostaglandin E1) | Alprostadil 20 µg ampoules; 60 µg alprostadil/d i.v. for 15 days. |
| OTHER | Placebo | Placebo/d i.v. for 15 days |
Timeline
- Start date
- 2006-07-01
- Primary completion
- 2010-02-01
- Completion
- 2010-02-01
- First posted
- 2008-02-20
- Last updated
- 2014-10-27
- Results posted
- 2011-04-11
Locations
6 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT00619229. Inclusion in this directory is not an endorsement.