PT003 MDI Cardiovascular Safety Study

Study identifier:PT003003

ClinicalTrials.gov identifier:NCT01349803

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double-blind, Parallel Group, 14-day, Multi-Center Study to Evaluate the Safety of PT003, PT005, PT001 and Foradil® Aerolizer® (12 µg, Open Label) as Evaluated by Holter Monitoring, in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 2

Healthy volunteers

No

Study drug

PT005 MDI, PT001 MDI, PT003 MDI, Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Sex

All

Actual Enrollment

237

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 01 May 2011
Primary Completion Date: 01 Nov 2011
Study Completion Date: 01 Nov 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2019 by Pearl Therapeutics, Inc.

Sponsors

Pearl Therapeutics, Inc.

Collaborators

-

Inclusion and exclusion criteria