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Endothelin Receptor Antagonist and Phosphodiesterase Type 5 Inhibitor

Macitentan + Tadalafil Combination for Pulmonary Arterial Hypertension (A DUE Trial)

Phase 3
Waitlist Available
Research Sponsored by Actelion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A woman of childbearing potential meeting specific pregnancy test and contraception requirements
Symptomatic PAH belonging to specific subgroups of WHO Group 1 pulmonary hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, edbt (up to 16 weeks)
Awards & highlights

A DUE Trial Summary

This trial will compare the efficacy of a fixed-dose combination of macitentan and tadalafil to that of macitentan or tadalafil given alone in patients with pulmonary arterial hypertension.

Who is the study for?
This trial is for people with symptomatic Pulmonary Arterial Hypertension (PAH) who are already on stable PAH medication. They should be able to walk a certain distance and meet specific health criteria. It's not for those with severe other diseases, recent changes in certain medications, or women who are pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests if a single pill combining macitentan and tadalafil is more effective than either drug alone for PAH. Participants will receive the combination therapy or one of the monotherapies with placebo to compare effects after 16 weeks.See study design
What are the potential side effects?
Possible side effects include liver problems, headache, anemia, respiratory tract infection, and symptoms like swelling or flushing. The combined tablet may also have similar side effects as when macitentan and tadalafil are taken separately.

A DUE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman who can have children and follow strict pregnancy prevention measures.
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I have symptoms of a specific type of high blood pressure in the lungs.
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I have been diagnosed with PAH and experience moderate symptoms.
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I have PAH with symptoms and it's related to a specific health condition or cause.
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I can walk between 100 and 450 meters in six minutes.
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I have been on a stable dose of ERA or PDE-5i for at least 3 months.

A DUE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, edbt (up to 16 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, edbt (up to 16 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Pulmonary Vascular Resistance (PVR) Expressed as the Ratio of Geometric Means of End of Double-blind Treatment (EDBT) to Baseline
Secondary outcome measures
Change From Baseline in 6-minutes Walking Distance (6MWD) to EDBT
Change From Baseline in Pulmonary Arterial Hypertension Symptoms and Impact (PAH-SYMPACT) in Cardiopulmonary Symptom Domain Scores to EDBT
Change From Baseline in Pulmonary Arterial Hypertension Symptoms and Impact (PAH-SYMPACT) in Cardiovascular Symptom Domain Scores to EDBT
+1 more

A DUE Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: FDC therapy + Placebo macitentan + Placebo tadalafilExperimental Treatment3 Interventions
Subjects to receive FDC macitentan/tadalafil (macitentan 10 mg and tadalafil 40 mg) plus matching placebos for the two other study treatments.
Group II: Tadalafil mono-therapy + Placebo macitentan + Placebo FDCActive Control3 Interventions
Subjects to receive tadalafil 40 mg (2 x 20 mg) plus matching placebos for the two other study treatments.
Group III: Macitentan mono-therapy + Placebo tadalafil + Placebo FDCActive Control3 Interventions
Subjects to receive macitentan 10 mg plus matching placebos for the two other study treatments.

Find a Location

Who is running the clinical trial?

ActelionLead Sponsor
191 Previous Clinical Trials
35,506 Total Patients Enrolled
66 Trials studying Pulmonary Arterial Hypertension
15,798 Patients Enrolled for Pulmonary Arterial Hypertension
Hany Rofael, MDStudy DirectorJanssen, LP

Media Library

FDC macitentan/tadalafil (Endothelin Receptor Antagonist and Phosphodiesterase Type 5 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03904693 — Phase 3
Pulmonary Arterial Hypertension Research Study Groups: Tadalafil mono-therapy + Placebo macitentan + Placebo FDC, Macitentan mono-therapy + Placebo tadalafil + Placebo FDC, FDC therapy + Placebo macitentan + Placebo tadalafil
Pulmonary Arterial Hypertension Clinical Trial 2023: FDC macitentan/tadalafil Highlights & Side Effects. Trial Name: NCT03904693 — Phase 3
FDC macitentan/tadalafil (Endothelin Receptor Antagonist and Phosphodiesterase Type 5 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03904693 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please specify how many hospitals are participating in this research project?

"There are 27 clinical trial locations for this study, some of which include Piedmont Healthcare in Atlanta, Georgia, Sanford Health in Sioux Falls, South dakota, and OSF HealthCare Cardiovascular Institute in Peoria, Illinois."

Answered by AI

Are new participants being enrolled in this trial at the present time?

"This study is not presently enrolling patients, as reflected on clinicaltrials.gov. The investigation was initially posted on 7/29/2019 and last updated on 10/11/2022. However, there are 811 other medical trials that are still recruiting individuals."

Answered by AI

How many more people can join this research project?

"This study is no longer enrolling new patients. The trial was posted on 7/29/2019 and updated for the last time on 10/11/2022. If you are looking for other trials, there are currently 788 studies actively searching for patients with hypertension and 23 trials for FDC macitentan/tadalafil that are still recruiting participants."

Answered by AI

Could you please inform me about other drug trials that have used FDC macitentan/tadalafil?

"FDC macitentan/tadalafil was first studied in 2008 by the Pulmonary Institute at Rabin Medical Center. There are now 147 completed clinical trials and 23 active studies. A significant number of these ongoing investigations are based out of Atlanta, Georgia."

Answered by AI

Has the FDA cleared FDC macitentan/tadalafil for use?

"Since this is a Phase 3 trial, there is some efficacy data and multiple rounds of safety data supporting the use of FDC macitentan/tadalafil. Therefore, our team at Power has rated its safety as a 3 on a scale from 1 to 3."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
What site did they apply to?
The University of North Carolina at Chapel Hill
University of Texas Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)
2019. "Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03904693.
All > Pulmonary Arterial Hypertension > Cialis
~33 spots leftby Apr 2025
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