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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 May 2024 |
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Main ID: |
NCT04826185 |
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Date of registration:
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18/03/2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy Trial
IMPROVE-HCM |
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Scientific title:
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A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy |
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Date of first enrolment:
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June 14, 2021 |
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Target sample size:
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67 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04826185 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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United Kingdom
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United States
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Contacts
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Contact type:
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Imbria Pharmaceuticals, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of Hypertrophic Cardiomyopathy consistent with current US and European
guidelines
- Ability to perform an upright treadmill cardiopulmonary exercise test
- Agreement to abide by contraceptive requirements
Exclusion Criteria:
- 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
- Women who are pregnant, planning to become pregnant or lactating
- Participation in another clinical study involving a test product or invasive medical
device within 28 days (or within 5 elimination half-lives of the respective test
product, whichever is longer), prior to first dosing
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Non-obstructive Hypertrophic Cardiomyopathy
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Intervention(s)
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Drug: IMB-1018972
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Drug: Placebo
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Primary Outcome(s)
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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: Baseline through Week 14 Safety Follow-up]
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Secondary Outcome(s)
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Change from baseline of peak oxygen consumption (VO2) and Oxygen uptake efficiency slope (OUES), measured by standardized cardiopulmonary exercise testing (CPET)
[Time Frame: Baseline, Week 12]
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Secondary ID(s)
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IMB101-007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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| Results available: |
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