CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study) +2 moregenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00454818
NCT00454818Phase 2Completed
CompareCT.gov

A Phase 1/2 Trial of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects With Heart Failure in Two Stages (Open-Label, Sequential Dose-Escalation Cohorts and Randomized, Double-Blind, Placebo-Controlled, Parallel Cohorts)

Celladon Corporation·interventional·Posted Apr 2, 2007·Updated Aug 20, 2014

In Brief

A Phase 2 clinical trial evaluating MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study), Placebo Infusion, and 1 other intervention for Heart Failure, Congestive and Dilated Cardiomyopathy. Completed, enrolled 51 participants across 22 sites.

Detailed Summary

The study is divided into 2 parts. In the first part, the safety of the gene transfer agent MYDICAR® will be evaluated. In the second part, the ability of MYDICAR® to improve heart function will be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Congestive, Dilated Cardiomyopathy
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2, 2007
Enrollment StartMar 1, 2007
Primary CompletionAug 1, 2010
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 19.3 years ago

Interventions

MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study)genetic

MYDICAR administered by antegrade epicardial coronary artery infusion

Placebo Infusionprocedure

Saline; epicardial coronary artery infusion

MYDICAR Phase 2 (Placebo-controlled, Randomized Study)genetic

MYDICAR administered by antegrade epicardial coronary artery infusion