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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: Completed Phase 2 study of Chronic Obstructive Pulmonary Disease, sponsored by Pearl Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary safety objective of this study was to compare the change in mean heart rate averaged over 24 hours post-dose, following twice daily dosing over 14 days with PT003 MDI, PT005 MDI, PT001 MDI or Foradil Aerolizer compared to baseline in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2011-05 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
What the finished NCT01349803 record still lists
NCT01349803 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, below the 1,751-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (86% lower).
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 names 20 study sites across 17 states, led by 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.
Learn More About Clinical Trials
Similar trials for Chronic Obstructive Pulmonary Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01349803's enrollment target sits among peer trials
237 36th of 86 higher than 51 of 86 other Chronic Obstructive Pulmonary Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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