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Trial record 1 of 1 for:    QVA149 ENLIGHTEN
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A Study to Assess the Long-term Safety of QVA149 (ENLIGHTEN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01120717
First received: May 5, 2010
Last updated: January 28, 2013
Last verified: January 2013
Results First Received: December 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: QVA149
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomization ratio in the study was 2:1 for QVA149 and Placebo groups. Patients were not stratified by COPD disease severity.

Reporting Groups
  Description
QVA149 110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
Placebo Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI

Participant Flow:   Overall Study
    QVA149   Placebo
STARTED   226   113 
Safety Population: Received Study Drug   225   113 
COMPLETED   194   89 
NOT COMPLETED   32   24 
Withdrawal by Subject                11                6 
Adverse Event                10                6 
Protocol Deviation                2                5 
Unsatisfactory Therapeutic Effect                3                3 
Lost to Follow-up                2                3 
Death                3                1 
Abnormal Test Procedure Result(s)                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
QVA149 110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
Placebo Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
Total Total of all reporting groups

Baseline Measures
   QVA149   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 225   113   338 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.5  (8.81)   62.9  (8.14)   62.6  (8.58) 
Gender 
[Units: Participants]
     
Female   51   27   78 
Male   174   86   260 


  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events, Serious Adverse Events or Death   [ Time Frame: 52 weeks + Follow-up (Up to Day 394) ]

2.  Secondary:   Pre-dose FEV1   [ Time Frame: 52 weeks ]

3.  Secondary:   Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period   [ Time Frame: 52 weeks ]

4.  Secondary:   Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period   [ Time Frame: 52 weeks ]

5.  Secondary:   Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period   [ Time Frame: 52 weeks ]

6.  Secondary:   Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period   [ Time Frame: 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 778-8300


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01120717     History of Changes
Other Study ID Numbers: CQVA149A2307
2009-013235-38 ( EudraCT Number )
Study First Received: May 5, 2010
Results First Received: December 13, 2012
Last Updated: January 28, 2013
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: Research Ethics Medical Committee
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
India: Drugs Controller General of India
Korea: Food and Drug Administration
Korea: Institutional Review Board
Latvia: State Agency of Medicines
Latvia: Institutional Review Board
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health
Romania: Ministry of Public Health
Romania: National Medicines Agency
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration