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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.
Register: EUCTR
Last refreshed on: 30 June 2019
Main ID:  EUCTR2011-004507-20-IT
Date of registration: 08/03/2012
Prospective Registration: No
Primary sponsor: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
Public title: SHMC
Scientific title: RANOLAZINE IN PATIENTS WITH SYMPTOMATIC HYPERTROPHIC CARDIOMYOPATHY: A PILOT STUDY ASSESSING THE EFFECTS ON EXERCISE CAPACITY, DIASTOLIC FUNCTION AND SYMPTOMATIC STATUS
Date of first enrolment: 22/02/2012
Target sample size: 100
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004507-20
Study type:  Interventional clinical trial of medicinal product
Study design: 
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: yes
Other specify the comparator: - same IMP used at different dosage
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Germany Italy Spain
Contacts
Name: Donatella Bemporad   
Address:  Via Sette Santi, 3 50131 Firenze Italy
Telephone: 0555680685
Email: DBemporad@menarini.it
Affiliation:  Menarini International Operations Lexembourg SA
Name: Donatella Bemporad   
Address:  Via Sette Santi, 3 50131 Firenze Italy
Telephone: 0555680685
Email: DBemporad@menarini.it
Affiliation:  Menarini International Operations Lexembourg SA
Key inclusion & exclusion criteria
Inclusion criteria:
• Male and female gender; • Females of childbearing potential or within two years from the menopause must have a negative urine pregnancy test (females of childbearing potential must be using adequate contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner); • Patients which fulfil conventional echocardiographic criteria for the diagnosis of SHCM: Maximum LV wall thickness >= 1.5 cm; • Patients aged > 18 years; • Patients with exertion symptoms and functional limitation (angina and or HF NYHA II-III); • Presence of sinus rhythm; • Peak V02 < 75% of predicted for age and gender; • Absence of resting LV outflow tract obstruction (peak gradient < 30 mmHg); • Written informed consent prior to enrolment into the study; Persons capable to understand the nature, significance and implications of the clinical trial.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion criteria:
• Females of childbearing potential not using adequate contraceptive precautions; • Females who are pregnant or lactating; • Presence of known coronary artery disease (CAD); • Presence of Chronic Obstructive Airways Disease; • Concomitant administration of potent CYP3A4 inhibitors • Concomitant administration of dronedarone Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone, or other QT-prolonging drugs; Concomitant use of CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St. John?s Wort) • Patients with QTc at baseline >= 500 ms; • Any clinically relevant haematological or biochemical abnormality on routine screening, according to Investigator`s judgment; • Severe concurrent pathology, including terminal illness (cancer, AIDS, etc.); • Severe renal impairment defined as GFR < 29 mL/min; creatinine level > 2.5 mg/dL; GFR must always be calculated; • Moderate or severe hepatic impairment or hepatic insufficiency defined as SGOT or SGPT > 2 times greater than normal upper limit or total serum bilirubin > 1.5 times greater than normal upper limit; • Dementia, psychosis, alcoholism (>280 g ethanol/week for male or >140 g ethanol/week for female patients) or chronic abuse of medicines, drugs or psychoactive substances; • Conditions which in the Investigator`s opinion may interfere with the study`s execution or due to which the patient should not participate for safety reasons; • Risk of low patient cooperation; • Inability or unwillingness to issue the informed consent; • Inability to perform a cardiopulmonary test; • Lactose intolerance; Hypersensitivity to ranolazine or one of the excipients.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
symptomatic hypertrophic cardiomyopathy (SHCM)
MedDRA version: 14.1 Level: PT Classification code 10020871 Term: Hypertrophic cardiomyopathy System Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Intervention(s)

Trade Name: RANEXA*60CPR 500MG R.P.
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RANOLAZINE
CAS Number: 95635-55-5
Current Sponsor code: Ranolazione PR
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: RANEXA*60CPR 750MG R.P.
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RANOLAZINE
CAS Number: 95635-55-5
Current Sponsor code: Ranolazione PR
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 750-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: RANEXA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RANOLAZINE
CAS Number: 95635-55-5
Current Sponsor code: Ranolazione PR
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: The primary study objective will be to demonstrate the efficacy of ranolazine in improving the Exercise capacity in patients affected by SHCM using the V02 peak technique
Primary end point(s): Evaluation of Exercise Capacity with the V02 peak in patients with SHCM after 5 months of treatment with ranolazine or placebo
Secondary Objective: Secondary objectives will be to demonstrate the efficacy of ranolazine on diastolic function, symptomatic status and natriuretic peptide biomarker proBNP in patients affected by SHCM. The assessment of safety by evaluation of adverse events, laboratory findings, the rest standard 12- lead ECG, detection of 24-hour arrhythmic burden by Holter ECG monitoring and physical examination will also be considered a secondary study objectives
Timepoint(s) of evaluation of this end point: after 5 months
Secondary Outcome(s)
Secondary end point(s): E/E' ratio evaluation; Natriuretic peptides biomarkers evaluation (proBNP biomarkers); Symptomatic Status evaluation (Minnesota Living With Heart Failure Questionnaire)
Timepoint(s) of evaluation of this end point: after 1 and 5 months
Secondary ID(s)
2011-004507-20-ES
MEIN/11/RAN-HCM/001
Source(s) of Monetary Support
Menarini International Operations Lexembourg SA
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available: Yes
Date Posted: 25/05/2016
Date Completed: 14/11/2014
URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-004507-20/results
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