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COMPLETED Phase 3

NVA237 Versus Placebo 12-week Efficacy Study

NCT01709864 · View on ClinicalTrials.gov ↗

Study Summary

The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug will be tested against a placebo treatment. The primary criterion to assess efficacy will be the difference between the serial lung function measurements of patients who have been treated for 12 weeks with NVA237 versus those that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1 testing) will be conducted and the "area under the curve" will be the measure for the ability to breathe.

Interventions

  • DRUG Placebo
  • DRUG NVA237

Study Locations (20)

Florida

  • Novartis Investigative Site — Brandon
  • Novartis Investigative Site — Clearwater
  • Novartis Investigative Site — DeFuniak Springs
  • Novartis Investigative Site — Edgewater
  • Novartis Investigative Site — Fort Lauderdale
  • Novartis Investigative Site — Hialeah
  • Novartis Investigative Site — Miami
  • Novartis Investigative Site — Miami
  • Novartis Investigative Site — Miami

California

  • Novartis Investigative Site — Fountain Valley
  • Novartis Investigative Site — Fullerton
  • Novartis Investigative Site — Los Angeles
  • Novartis Investigative Site — Los Angeles
  • Novartis Investigative Site — Riverside
  • Novartis Investigative Site — San Diego
  • Novartis Investigative Site — San Diego

Alabama

  • Novartis Investigative Site — Homewood
  • Novartis Investigative Site — Jasper

Arizona

  • Novartis Investigative Site — *See Various Dept.'s*
  • Novartis Investigative Site — Tucson

Trial Details

FieldValue
Enrollment Target 440 participants
Start Date 2012-11
Est. Completion 2013-10
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01709864

The ClinicalTrials.gov registry entry for NCT01709864 describes a study currently listed as completed. It is categorized as Phase 3, 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 440 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 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 2 interventions — of which Placebo 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: NCT01709864 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Florida, California, Alabama. 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 NCT01709864 about?

NCT01709864 is a clinical study titled "NVA237 Versus Placebo 12-week Efficacy Study". The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug will be tested against a placebo treatment. The primary criterion to ...

What is the current status of trial NCT01709864?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 440 participants. The study started on 2012-11. Estimated completion is 2013-10.

What conditions does trial NCT01709864 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 NCT01709864?

The interventions under investigation include: Placebo (DRUG), NVA237 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01709864?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01709864 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida. 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