Skip to main content
OpenTrials
Completed

NCT Number: NCT02070991

Clinical 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

Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left ventricular dysfunction.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Krankenhaus der Elisabethinen Linz, 2. Interne Abteilung, Linz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Types of Pulmonary Hypertension other than WHO groups 2.1 and 2.2 (Nice classification)
  • Administration of PAH-specific therapy (i.e., Endothelin receptor antagonists (ERAs), Prostanoids, Phosphodiesterase 5 (PDE-5) inhibitors, guanylate cyclase stimulators)

Treatment and study plan

Macitentan

Drug

oral tablet, 10 mg once daily

Other names: ACT-064992

Placebo

Drug

matching placebo

Other names: matching placebo

Primary outcomes

  1. Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment

    Time frame: From randomization up to End-of-Study (Week 12 + 30 days follow-up) plus 1 calendar day

    The main endpoint is the number of participants who had at least one of the following: A) significant fluid retention, defined as increase in body weight at any time by ≥ 5% or ≥ 5 kg from baseline due to fluid overload and/or parenteral administration of diuretics. B) Worsening of NYHA functional class from baseline.

Secondary outcomes

  1. NT-proBNP at Week 12 Expressed as Percent of Baseline NT-proBNP at Rest

    Time frame: From randomization up to end of treatment period (Week 12)

  2. PVR at Rest at Week 12 Expressed as Percent of Baseline PVR at Rest

    Time frame: From randomization up to end of treatment period (Week 12)

    Pulmonary vascular resistance (PVR) was assessed at rest by right heart catheterization (RHC).

  3. Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP)

    Time frame: From randomization up to end of treatment period (Week 12)

  4. Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)

    Time frame: From randomization up to end of treatment period (Week 12)

  5. Change From Baseline to Week 12 in Pulmonary Artery Wedge Pressure (PAWP)

    Time frame: From randomization up to end of treatment period (Week 12)

  6. Change From Baseline to Week 12 in Cardiac Index (CI)

    Time frame: From randomization up to end of treatment period (Week 12)

  7. Change From Baseline to Week 12 in Diastolic Pulmonary Vascular Pressure Gradient (DPG)

    Time frame: From randomization up to end of treatment period (Week 12)

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study title

A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, 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

Acronym: MELODY-1

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 25, 2014
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.