CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Tadalafil +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01862536
NCT01862536Phase 2Completed

Tadalafil for Pulmonary Hypertension Associated With Chronic Lung Disease

VA Office of Research and Development·interventional·Posted May 24, 2013·Updated Mar 9, 2021

In Brief

A Phase 2 clinical trial evaluating Tadalafil and placebo for Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 44 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 24, 2013
Enrollment StartOct 1, 2013
Primary CompletionAug 31, 2019
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 13.1 years ago

Interventions

Tadalafildrug

Daily use of study drug to treat pulmonary hypertension.

placebodrug

Daily use in double blind study.