Trial document




drksid header

  DRKS00007158

Trial Description

start of 1:1-Block title

Title

A prospective, multicenter, double-blind, randomized, placebocontrolled, parallel group, 12-week study to evaluate the safety and tolerability of Macitentan in subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left ventricular dysfunction.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Melody-1

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://n/a

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Left heart failure may cause Pulmonary Hypertension, a serious medical condition in which the pressure in the blood vessels going to the lungs (the pulmonary arteries) is higher than normal.
Macitentan is a drug that is registered for the treatment of pulmonay-arterial hypertension. The aim of the Melody-1 trial is to evaluate whether Macitentan iis also safe and tolerated in patients with pulmonary hypertension secondary to left heart failure. The primary aim of the trial is to evaluate the safety and the tolerability of Macitentan especially with regard to the body water retention (e.g. water retention in the legs). Additionally it will be tested whether Macitentan is able to lower the resistance in the pulmonary vessels and the in the pulmonary artery. Such effects are expected to have a positive impact on the exercise capacity.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

MELODY-1 is a study of macitentan in patients with CpcPH due to left ventricular dysfunction. The primary objective of the study is to evaluate the safety and tolerability of macitentan in subjects with CpcPH.
The secondary objective is to evaluate the efficacy of macitentan in subjects with CpcPH.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00007158
  •   2014/11/13
  •   2014/02/21
  •   no
  •   Approved
  •   14-037, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2013-003822-96 
  •   NCT02070991  (ClinicalTrials.gov)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Left Ventricular Dysfunction
  •   Post-capillary Pulmonary Hypertension
  •   Pre-capillary Pulmonary Hypertension
  •   I50.12 -  [generalization I50.1: Left ventricular failure]
  •   I50.13 -  [generalization I50.1: Left ventricular failure]
  •   I27.28 -  [generalization I27.2: Other secondary pulmonary hypertension]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Macitentan 10 mg, tablet, oral, once daily for 12 weeks
  •   Placebo, tablet, oral, once daily for 12 weeks
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, data analyst
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Proportion of subjects experiencing one of the following up to end-of-treatment:
-Significant fluid retention, defined as one of the following:
a) Increase in body weight at any time by ≥ 5% or ≥ 5 kg from baseline due to fluid overload.
b) Parenteral administration of diuretics.
-Worsening in NYHA functional class from baseline.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Main secondary endpoints:
- pulmonary vascular resistance at rest at Week 12 expressed as percent of baseline value at rest.
-Change from baseline to Week 12 in mean right atrial pressure, mean pulmonary artery pressure, cardiac index, cardiac output, total pulmonary resistance, transpulmonary gradient, diastolic pulmonary pressure gradient, and mixed venous oxygen saturation at rest.
- change from baseline to Week 12 in echocardiographic parameters of diastolic and systolic function (i.e., left ventricular ejection fraction, tricuspid annular plane systolic excursion, tricuspid regurgitation velocity, diastolic wall thickness of the septum and the left ventricular free wall, E/e' ratio, left atrial volume).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Austria
  •   Belgium
  •   Canada
  •   Czech Republic
  •   France
  •   Germany
  •   Israel
  •   Italy
  •   Spain
  •   Switzerland
  •   United States
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/10/27
  •   60
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

1. Males and Females >=18 years of age
2. Subjects with combined pre-and post-capillary Pulmonary Hypertension (CpcPH) due to left ventricular dysfunction (subset of WHO groups 2.1 and 2.2)
3. Optimized diuretic therapy

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

1. Types of Pulmonary Hypertension other than WHO groups 2.1 and 2.2 (Nice classification)
2. Administration of pulmonary arterial hypertension-specific therapy (i.e., endothelin receptor antagonists (ERAs), prostanoids, phosphodiesterase 5 (PDE-5) inhibitors, guanylate cyclase stimulators)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Actelion Pharmaceutical Ltd
    • Gewerbestrasse 16
    • 4123  Allschwill
    • Switzerland
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Köln, Herzzentrum,Klinik III für Innere Medizin
    • Mr.  Prof. Dr. med.  Stephan  Rosenkranz 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Köln, Herzzentrum,Klinik III für Innere Medizin
    • Mr.  Prof. Dr. med.  Stephan  Rosenkranz 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Actelion Pharmaceutical Ltd
    • Gewerbestrasse 16
    • 4123  Allschwill
    • Switzerland
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.