Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease (IMPROVE-Ischemia)

NCT ID: NCT04826172

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-23
• Study Completion Date: 2023-09-21

Brief Summary

The purpose of this study is to assess the safety and tolerability of IMB-1018972 in subjects with obstructive CAD and inducible ischemia.

Conditions

Ischemia; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IMB-1018972 200mg

Group Type: EXPERIMENTAL

IMB-1018972

Intervention Type: DRUG

Modified release (MR) oral tablet

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching oral tablet

Interventions

IMB-1018972

Modified release (MR) oral tablet

Intervention Type: DRUG

Placebo

Matching oral tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Documented history of stable angina (CCS grading I-III) or anginal equivalent for ≥1 month prior to screening
• Ability to safely abstain from beta blockers for 48 hours prior to echo examinations in the opinion of the Investigator
• Preserved LV systolic function, defined as LVEF≥50% by any imaging modality
• Obstructive CAD and recent evidence of stress-induced myocardial ischemia

Exclusion Criteria

• Women of childbearing potential or who are currently pregnant or breast-feeding
• Clinically indicated for coronary revascularization (PCI/CABG) at time of screening or clinically significant LMS or proximal LAD stenosis likely to warrant revascularization during the study period in the opinion of the investigator.
• Type 1 insulin dependent diabetes mellitus (IDDM)
• Presence of pacemaker, cardiac resynchronization therapy and/or implantable cardioverter defibrillator
• Severe or clinically significant valvular heart disease
• Clinically significant concurrent condition which could prevent the patient from performing any of the protocol-specified assessments, represent a safety concern if the patient participates in the trial or could confound trial assessments of safety or tolerability

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imbria Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor, MD

Role: STUDY_CHAIR

Imbria Pharmaceuticals, Inc.

Locations

Imbria Investigational Site

Aarhus, , Denmark

Imbria Investigational Site

Turku, , Finland

Imbria Investigational Site

Uppsala, , Sweden

Countries

Denmark; Finland; Sweden

Other Identifiers

IMB101-006

Identifier Type: -

Identifier Source: org_study_id