Completed

A Phase Ib Randomized, Placebo-controlled, Double-blinded Study Evaluating the Safety of Ataciguat (HMR1766) in Patients With Moderate Calcific Aortic Valve Stenosis

What is being tested

Ataciguat

+ Placebo

Drug

Who is being recruted

Aortic Valve Disease+3

+ Aortic Valve Stenosis

+ Cardiovascular Diseases

Over 50 Years

+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Placebo-ControlledPhase 1

Interventional

Study Start: January 2014

See protocol details

Summary

Principal SponsorJordan D. Miller, Ph.D.

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2014

Actual date on which the first participant was enrolled.

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.

Official TitleA Phase Ib Randomized, Placebo-controlled, Double-blinded Study Evaluating the Safety of Ataciguat (HMR1766) in Patients With Moderate Calcific Aortic Valve Stenosis

NCT02049203

Principal SponsorJordan D. Miller, Ph.D.

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

44 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Aortic Valve DiseaseAortic Valve StenosisCardiovascular DiseasesHeart DiseasesHeart Valve DiseasesVentricular Outflow Obstruction

Criteria

5 inclusion criteria required to participate

Age > 50 years

Male or female sex

Aortic valve area greater than 1.0 cm2 but less than 2.0 cm2

Aortic valve calcium levels greater than 300 arbitrary units from chest CT

Show More Criteria

14 exclusion criteria prevent from participating

History of orthostatic intolerance or symptomatic hypotension

Positive pregnancy test during screening visit

Nitrate use or α-antagonist medication use within 24 hours

Systolic blood pressure <110 mm Hg

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Ataciguat, orally administered gel capsule, 50, 100, or 200 mg, once per day with breakfast for 14 consecutive days

Group II

Placebo

Placebo gel capsule, dosage matches number of Ataciguat capsules for each respective dose, capsules taken once daily with breakfast for 14 consecutive days.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Mayo Clinic in Rochester

Rochester, United StatesOpen Mayo Clinic in Rochester in Google Maps

CompletedOne Study Center