At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 35 enrolled
Drug / intervention
Ataciguat (HMR1766) +1 moredrug
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.
A Phase II Randomized, Placebo-Controlled, Double-Blinded Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification in Patients With Moderate Calcific Aortic Valve Stenosis
In Brief
A Phase 2 clinical trial evaluating Ataciguat (HMR1766) and Placebo Comparator: Matching Placebo for Aortic Valve Stenosis. Completed, enrolled 35 participants across 1 site.
Detailed Summary
The primary objective of the current study is to determine whether Ataciguat (HMR1766) slows progression of valve calcification in patients with moderate calcific aortic valve stenosis. Secondary and tertiary objectives are to determine whether Ataciguat slows progression of aortic valve function, reduces systemic inflammation, and prevents left ventricular dysfunction in patients with moderate calcific aortic valve stenosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Stenosis
CountriesUnited States
CollaboratorsSanofi, National Institutes of Health (NIH)
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJun 2015
First PostedJun 2015
Primary CompletionJul 2018
Study CompletionDec 2019
TodayJul 2026
First PostedJun 25, 2015
Enrollment StartJun 1, 2015
Primary CompletionJul 1, 2018
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.0 years ago
Interventions
Ataciguat (HMR1766)drug
Placebo Comparator: Matching Placeboother