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PT003 MDI Cardiovascular Safety Study

NCT01349803 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2017-01-31

Study results available
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Summary

This study is primarily a safety study. The primary and secondary endpoints are based on 24-hour Holter monitor assessments obtained on Day 14 relative to baseline.

Conditions

Interventions

DRUG

PT005 MDI

PT005 MDI administered as two puffs BID for 14 days

DRUG

PT001 MDI

PT001 MDI administered as two puffs BID for 14 days

DRUG

PT003 MDI

PT003 MDI administered as two puffs BID for 14 days

DRUG

Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days

Sponsors & Collaborators

  • Pearl Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Colin Reisner, M.D. · Pearl Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01349803 on ClinicalTrials.gov