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NCT02070991 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Actelion.

Completed
Registry status
Phase 2
Development phase
63
Enrollment target

NCT02070991: Completed Phase 2 study, sponsored by Actelion.

NCT02070991 is a Phase 2 study that has completed, run by Actelion. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02070991, a Phase 2 study, has completed, sponsored by Actelion.

COMPLETED
Registry status
Phase 2
Development phase
63 participants
Enrollment target

Study Summary

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.

Primary Outcome

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.

Interventions

  • DRUG Placebo
  • DRUG Macitentan

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2014-07-01
Est. Completion 2015-11-01
Phase Phase 2
Actelion

63 total trials

What the finished NCT02070991 record still lists

NCT02070991 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02070991 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02070991 about?

NCT02070991 is a clinical study titled "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.

What is the current status of trial NCT02070991?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2014-07-01. Estimated completion is 2015-11-01.

What interventions are being tested in trial NCT02070991?

The interventions under investigation include: Placebo (DRUG), Macitentan (DRUG).

Who is sponsoring clinical trial NCT02070991?

This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02070991's enrollment target sits among peer trials

63 1009th of 2000 higher than 985 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02070991, the US trial registry maintained by the National Library of Medicine. NCT02070991 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.