Safety of Ataciguat in Patients With Moderate Calcific Aortic Valve Stenosis

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Jordan D. Miller, Ph.D.
Study ID
NCT02049203
Phase
PHASE1
Status
Completed

Conditions

  • Aortic Valve Stenosis

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study will determine whether Ataciguat (HMR1766) is well-tolerated in patients with mild to moderate calcific aortic valve stenosis. The primary focus of these studies will be on changes in blood pressure and orthostatic tolerance (i.e., ability to stand up without passing out), and determining whether treatment with Ataciguat results in significant reductions in blood pressure in this patient population.

Key Dates

Start date
Jan 31, 2014
Status verified
Jul 2016
Primary completion
Mar 31, 2015
Completion
Mar 31, 2015

Study Design

Enrollment
44 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Placebo
    Placebo gel capsule, dosage matches number of Ataciguat capsules for each respective dose, capsules taken once daily with breakfast for 14 consecutive days.
  • Active Comparator: Ataciguat
    Ataciguat, orally administered gel capsule, 50, 100, or 200 mg, once per day with breakfast for 14 consecutive days

Primary Outcome Measure

Number of patients experiencing orthostatic hypotension [ Time Frame: Baseline - 14 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Rochester, MN

By research site
Mayo Clinic in Rochester· Rochester, MN

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