Trial · Interventional
WithdrawnPhase 1Registry dataA Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure
This trial was withdrawn before it enrolled anyone.
The registry gives no reason.
Overview
- Status
- Withdrawn
- Phase
- Phase 1
- Enrollment
- 0 participants (actual)
- Sponsor
- Stealth BioTherapeutics Inc. · Industry
- Design
- Randomized · Triple masking
- Countries
1 country
Bulgaria
- Start
- May 2015
- Primary completion
- Sept 2015 (estimated)
- Completion
- Oct 2015 (estimated)
- First posted
- 17 Mar 2015 (estimated)
- Last update posted
- 15 Oct 2015 (estimated)
- Conditions
- Heart Failure
Timeline
1 trial · 1 stopped early
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1Withdrawn
A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure
NCT02388529May 2015 to est. Oct 2015
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study is a single-center, randomized, double-blind, placebo-controlled study in patients with stable heart failure to evaluate the safety, tolerability, pharmacokinetics, and efficacy of multiple ascending doses of Bendavia™ (MTP-131) intravenous infusion.
Interventions
- MTP-131Drug
- MTP-131Drug
- MTP-131Drug
- PlaceboDrug
Arms4
Experimental
Low dose
Experimental
Intermediate dose
Experimental
High dose
Placebo comparator
Placebo
Primary outcomes2
Outcomes the sponsor listed as primary.
Incidence of Adverse Events
Time frame · Assessed up to Day 33
Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort
Time frame · Assessed up to Day 12
Secondary outcomes(1)
Changes in echocardiographic LV end-systolic volume (LVESV)
Time frame · Assessed up to Day 33
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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