Trials / Completed
CompletedNCT01643330
A Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure
A Phase 2b, Double-Blind, Placebo-Controlled, Multinational, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects With Heart Failure
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 250 (actual)
- Sponsor
- Celladon Corporation · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this trial is to assess whether MYDICAR can reduce the frequency and/or delay heart failure related hospitalizations in persons with advanced heart failure when added to their maximal and optimized therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | AAV1/SERCA2a (MYDICAR) | Single intracoronary infusion 1 x 10\^13 DNase Resistant Particles (DRP) MYDICAR |
| GENETIC | Placebo | Single intracoronary infusion |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2015-02-01
- Completion
- 2016-02-01
- First posted
- 2012-07-18
- Last updated
- 2016-03-24
Locations
54 sites across 10 countries: United States, Belgium, Denmark, Germany, Hungary, Israel, Netherlands, Poland, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT01643330. Inclusion in this directory is not an endorsement.