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NCT01862536 · ClinicalTrials.gov registry record · Phase 2

Tadalafil for Pulmonary Hypertension Due to Chronic Lung Disease

A Phase 2 study, sponsored by VA Office of Research and Development.

Completed
Registry status
Phase 2
Development phase
44
Enrollment target

NCT01862536: Completed Phase 2 study, sponsored by VA Office of Research and Development.

NCT01862536 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01862536, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
Phase 2
Development phase
44 participants
Enrollment target

Study Summary

The functional, social, and economic burden of chronic obstructive lung disease (COPD) on the healthcare system is extraordinary. COPD is the fourth leading cause of death in the United States, and some estimates attribute up to $33.2 billion in health care costs to COPD-associated morbidity and mortality annually. The burden of COPD to the VA Healthcare system parallels these findings. According to the VA HSR\&D Health Economics Resource Center, COPD ranks 5th among the 40 most common chronic clinical conditions in the U.S. Veteran patient population, is responsible for \>14,000 VA hospital admission annually, and increases by $1,051/patient the total annual health care cost burden on the VA Healthcare system. Importantly, COPD is associated with frequent emergency room visitation and/or hospitalization patients. Pulmonary hypertension is a common co-morbid condition that worsen morbidity and mortality in patients with COPD. This study will examine the potential for tadalafil, a phosphodiesterase type-5 (PDE-5) inhibitor to improve functional status by decreasing pulmonary hypertension. Results from this study are expected to define the potential use of PDE-5 inhibitors in COPD-induced pulmonary hypertension. If successful, this treatment option may improve quality of life and outcomes for the large number of Veterans afflicted with PH due to COPD.

Primary Outcome

Change from baseline in distance walked in 6 minutes.

Interventions

  • DRUG placebo
  • DRUG Tadalafil

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2013-10-01
Est. Completion 2019-08-31
Phase Phase 2
VA Office of Research and Development

1,668 total trials

What the finished NCT01862536 record still lists

NCT01862536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).

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

NCT01862536 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01862536 about?

NCT01862536 is a clinical study titled "Tadalafil for Pulmonary Hypertension Due to Chronic Lung Disease". The functional, social, and economic burden of chronic obstructive lung disease (COPD) on the healthcare system is extraordinary. COPD is the fourth leading cause of death in the United States, and some estimates attribute up to $33.2 billion in health care costs to COPD-associated morbidity and mor...

What is the current status of trial NCT01862536?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2013-10-01. Estimated completion is 2019-08-31.

What interventions are being tested in trial NCT01862536?

The interventions under investigation include: placebo (DRUG), Tadalafil (DRUG).

Who is sponsoring clinical trial NCT01862536?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01862536's enrollment target sits among peer trials

44 1322nd of 2000 higher than 669 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 NCT01862536, the US trial registry maintained by the National Library of Medicine. NCT01862536 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.