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COMPLETED Phase 2

PT003 MDI Cardiovascular Safety Study

NCT01349803 · View on ClinicalTrials.gov ↗

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

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01349803

The ClinicalTrials.gov registry entry for NCT01349803 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 237 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pearl Therapeutics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01349803 reports 20 study locations spanning 17 distinct geographic areas — top geographies include California, South Australia, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01349803?

This trial is sponsored by Pearl Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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