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Trial record 2 of 3 for:    IMB-101
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Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease (IMPROVE-Ischemia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04826172
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : November 4, 2022
Sponsor:
Information provided by (Responsible Party):
Imbria Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ischemia Coronary Artery Disease Drug: IMB-1018972 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease
Actual Study Start Date : April 23, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: IMB-1018972 200mg Drug: IMB-1018972
Modified release (MR) oral tablet
Placebo Comparator: Placebo Drug: Placebo
Matching oral tablet


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability of IMB-1018972 as measured by incidence and severity of treatment emergent AEs (including AEs leading to study drug discontinuation and AEs leading to death), as well as incidence of treatment emergent SAEs [ Time Frame: Randomization through Week 10 Safety Follow-up ]

Secondary Outcome Measures :
  1. Change in number of ischemic segments during hyperemia (ischemia defined as absolute MBF ≤2.0 ml/kg/min) as measured by adenosine stress 15O-H2O PET [ Time Frame: Baseline through Week 8 ]
    Ischemia score defined on the basis of absolute hyperemic MBF as: (1) MBF 2.0-2.3 ml/g/min; (2) 1.7- 2.0 ml/g/min; (3) MBF <1.7 ml/g/min

  2. Change in total ischemia burden measured as ischemia score summed across all segments as measured by adenosine stress 15O-H2O PET [ Time Frame: Baseline through Week 8 ]
  3. Change in inducible perfusion defect expressed as % of myocardium as measured by adenosine stress 15O-H2O PET [ Time Frame: Baseline through Week 8 ]

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04826172


Contacts
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Contact: Medical Monitor +1(617) 675-4060 info@imbria.com

Locations
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Denmark
Imbria Investigational Site Recruiting
Aarhus, Denmark
Contact: Study Coordinator    +45 78456260    info@imbria.com   
Finland
Imbria Investigational Site Recruiting
Turku, Finland
Contact: Study Coordinator    +35 8405106241    info@imbria.com   
Sweden
Imbria Investigational Site Recruiting
Uppsala, Sweden
Contact: Study Coordinator    +46 (0)70 529 1121    info@imbria.com   
Sponsors and Collaborators
Imbria Pharmaceuticals, Inc.
Investigators
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Study Chair: Medical Monitor, MD Imbria Pharmaceuticals, Inc.
More Information
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Responsible Party: Imbria Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04826172    
Other Study ID Numbers: IMB101-006
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: November 4, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes