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NCT01349803 · ClinicalTrials.gov registry record · Phase 2

PT003 MDI Cardiovascular Safety Study

A Phase 2 study of Chronic Obstructive Pulmonary Disease, sponsored by Pearl Therapeutics.

Completed
Registry status
Phase 2
Development phase
237
Enrollment target
20
Study locations

NCT01349803 is a Phase 2 study of Chronic Obstructive Pulmonary Disease that has completed, run by Pearl Therapeutics. The registered enrollment target is 237 participants, below the 1,751-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT01349803, a Phase 2 study of Chronic Obstructive Pulmonary Disease, has completed, sponsored by Pearl Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
237 participants
Enrollment target
20
Study locations

Study 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.

Interventions

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

Study Locations (20)

California

  • Pearl Investigative Site - Fullerton
  • Pearl Investigative Site - Los Angeles
  • Pearl Investigative Site - San Diego

South Australia

  • Pearl Investigative Site - Dawpark
  • Pearl Investigative Site - Toorak Gardens

Arizona

  • Pearl Investigative Site - Glendale

Florida

  • Pearl Investigative Site - Pensacola

Louisiana

  • Pearl Investigative Site - Lafayette

Massachusetts

  • Pearl Investigative Site - North Dartmouth

Michigan

  • Pearl Investigative Site - Livonia

Oregon

  • Pearl Investigative Site - Medford

Trial Details

FieldValue
Enrollment Target 237 participants
Start Date 2011-05
Est. Completion 2011-11
Phase Phase 2

Sponsor

Pearl Therapeutics

31 total trials

What the Registry Record Tells You About NCT01349803

The ClinicalTrials.gov registry entry for NCT01349803 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 237 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,751-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (86% lower). The listed sponsor is Pearl Therapeutics, which has 31 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 4 interventions - of which PT003 MDI is the first listed.

NCT01349803 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, South Australia, Arizona.

Frequently Asked Questions

What is clinical trial NCT01349803 about?

NCT01349803 is a clinical study titled "PT003 MDI Cardiovascular Safety Study". 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.

What is the current status of trial NCT01349803?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 237 participants. The study started on 2011-05. Estimated completion is 2011-11.

What conditions does trial NCT01349803 study?

This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease.

What interventions are being tested in trial NCT01349803?

The interventions under investigation include: PT003 MDI (DRUG), PT005 MDI (DRUG), Formoterol Fumarate 12 μg (Foradil® Aerolizer®) (DRUG), PT001 MDI (DRUG).

Who is sponsoring clinical trial NCT01349803?

This trial is sponsored by Pearl Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01349803 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.