jRCTs031180038CompletedNot Applicable
A multicenter, open-label, single-arm study of a TRPV2 inhibitor against cardiomyopathy of muscular dystrophy (Tranilast-MD)
Not provided0 sites20 target enrollmentStarted: December 18, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Primary Endpoint
- The change in BNP
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Single Arm Study
- Intervention Model
- Single Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 13age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •MD patients aged 13 or more
- •With high value in BNP (100 pg/mL or more)
- •Those introduced with standard myocardium protective drugs (angiotensin converting enzyme inhibitor (ACEI)/angiotensin type II receptor blocker (ARB) and/or beta blocker) who meets both of the following:
- •taking maintenance doses at the time of consent;
- •whose dosage regimen and doses are fixed from 2 weeks before the start of administration until the start of administration.
- •To whom intrinsic administration of capsule, fine granules or dry syrup is possible, or who can be reliably administered tranilast by tube
- •Provided written consent by their free will / the representative
Exclusion Criteria
- •Acute stage heart failure condition (using cardiotonic, diuretic, antiarrhythmic drug intravenously)
- •From 2 weeks before the start of administration to the start of administration Directions of digitalis, diuretic, aldosterone antagonist, cardiotonic agent, antiarrhythmic drug are not fixed
- •With a lethal arrhythmia including ventricular premature contraction of more than four (short run)), excluding those with transplanted implantable defibrillators
- •With serious renal dysfunction (estimated glomerular filtration ratio (eGFR) using cystatin C of less than 30 mL/min/1.73 m2)
- •Male: eGFR = (104 ^ Cystatin C-1.019^ 0.996age (years)) - 8
- •Female: eGFR = (104 ^ Cystatin C-1.019 ^ 0.996age (years) ^ 0.929) - 8
- •For those aged 18 or less, cyctain C of 2.5 mg/L or more is used.
- •With severe liver function disorder (T. Bil of 10 mg/dl or more, AST and ALT of 500 IU/L or more, ALP of 5 times or more of the normal upper limit, PT of 40% or less, bleeding tendency, hepatic failure symptoms (fulminant hepatitis), cirrhosis of the liver, liver tumor, jaundice prolonged for more than 6 months) (equivalent to grade 3 in "Classification criteria for severity of adverse drug reactions" )
- •Marked white blood cell (WBC) decrease (less than 3000/mm^3), platelet (Plt) decrease (less than 80,000/mm^3)
- •Having a history of hypersensitivity to tranilast
- •Pregnant or possibly pregnant
- •For whom the principal investigator/sub-investigators judged not appropriate for participation in this study
Outcomes
Primary Outcomes
The change in BNP
Time Frame: 24 weeks
The change in BNP before the start of administration (using the average of values in the pre-treatment observation period and at the start of administration) to 24 weeks (using the average of values at 20 weeks, 24 weeks and 28 weeks)
Secondary Outcomes
- Cardiac events
Investigators
Similar Trials
Active, not recruiting
Phase 1
A randomized, Phase 1b, single-center, observer-blind, active-controlled study to evaluate the safety, immunogenicity, and immunological mechanisms of one single administration of TETRALITE influenza vaccine at two dose levels of LiteVax Adjuvant, in healthy participants aged 60 years and older and in healthy participants aged 18 to 50 years.MedDRA version: 20.0Level: PTClassification code: 10022000Term: Influenza Class: 100000004862InfluenzaCTIS2023-508230-33-00iteVax B.V.70
Active, not recruiting
Not Applicable
/AMedDRA version: 14.1Level: LLTClassification code 10062357Term: SIRSSystem Organ Class: 10018065 - General disorders and administration site conditionsMedDRA version: 14.1Level: LLTClassification code 10040072Term: SepticaemiaSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-000748-81-FIJohanna Hästbacka
Active, not recruiting
Phase 1
Study of safety, tolerability, pharmacokinetics and pharmacodynamics of MSD-001 in healthy participantsMental health disordersCTIS2024-512939-67-00Mindstate Design Labs Inc.68
Recruiting
Phase 1
Tramadol Administered Orally to Healthy Subjects for the Improvement of its Detection in Biological Matrices in the Context of Anti-Doping Controlhealthy subjectsMedDRA version: 21.0Level: LLTClassification code: 10076471Term: Drug doping Class: 10022117CTIS2023-503799-25-00Parc De Salut Mar25
Completed
Not Applicable
MDS-NMS TRANSLATION PROGRAMparkinson's diseasejRCT1030220360Genko Oyama300