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A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification

NCT02481258 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-01-22

Study results available
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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.

Conditions

  • Aortic Valve Stenosis

Interventions

DRUG

Ataciguat (HMR1766)

OTHER

Placebo Comparator: Matching Placebo

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • National Institutes of Health (NIH)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Jordan D Miller, PhD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-07-01
Completion
2019-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02481258 on ClinicalTrials.gov