Clinical Trials Directory

Trials / Terminated

TerminatedNCT00874497

Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema

A Multi-center, Randomized, Double-blind, Placebo-controlled Pilot Study to Assess the Pharmacodynamics, Efficacy and Safety of 50 mg Tetomilast Administered as Oral Tablets in Patients With Chronic Obstructive Pulmonary Disease Associated With Emphysema THIS STUDY IS CLOSED TO ENROLLMENT AND NEW SITES

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
84 (actual)
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
Sex
All
Age
40 Years – 75 Years
Healthy volunteers
Not accepted

Summary

Phase 2a multicenter, randomized, double-blind, placebo-controlled study to assess the pharmacodynamics, efficacy, and safety of tetomilast in patients with emphysema.

Conditions

Interventions

TypeNameDescription
DRUGtetomilastOral tetomilast 25 mg once daily for 2 weeks followed by 50 mg once daily for 2 years.
DRUGplaceboPlacebo for 104 weeks (2 years)

Timeline

Start date
2009-03-01
Primary completion
2015-07-01
Completion
2015-08-01
First posted
2009-04-02
Last updated
2017-04-17
Results posted
2017-04-17

Locations

15 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00874497. Inclusion in this directory is not an endorsement.

Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema (NCT00874497) · Clinical Trials Directory