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A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT00557466
Recruitment Status : Completed
First Posted : November 14, 2007
Results First Posted : January 18, 2013
Last Update Posted : January 18, 2013
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition COPD
Interventions Drug: indacaterol
Drug: formoterol
Drug: placebo to indacaterol
Drug: placebo to formoterol
Drug: short acting β2- agonist
Enrollment 568
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Indacaterol 62.5 μg Indacaterol 125 μg Indacaterol 250 μg Indacaterol 500 μg Formoterol Placebo
Hide Arm/Group Description Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Period Title: Overall Study
Started 98 92 101 96 90 91
Safety Population 98 [1] 92 [1] 101 [1] 96 [1] 90 [1] 91 [1]
Intent to Treat Population 98 [2] 91 [2] 98 [2] 93 [2] 87 [2] 89 [2]
Completed 94 87 95 92 87 85
Not Completed 4 5 6 4 3 6
Reason Not Completed
Adverse Event             3             1             4             1             2             4
Abnormal laboratory value(s)             1             2             0             0             0             0
Protocol deviation             0             1             0             2             0             0
Subject withdrew consent             0             0             0             0             1             2
Administrative problems             0             1             1             0             0             0
Abnormal test procedure results             0             0             1             0             0             0
Lost to Follow-up             0             0             0             1             0             0
[1]
All randomized patients who received at least one dose of the study drug
[2]
All randomized patients who had a baseline and at least one post-dose FEV1 measurement
Arm/Group Title Indacaterol 62.5 μg Indacaterol 125 μg Indacaterol 250 μg Indacaterol 500 μg Formoterol Placebo Total
Hide Arm/Group Description Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. Total of all reporting groups
Overall Number of Baseline Participants 98 91 98 93 87 89 556
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants 91 participants 98 participants 93 participants 87 participants 89 participants 556 participants
62.1  (7.69) 61.6  (9.51) 61.6  (8.68) 61.9  (8.48) 63.3  (8.36) 62.2  (8.84) 62.1  (8.58)
[1]
Measure Description: Total number of baseline participants is based on the Intent to Treat Population
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 91 participants 98 participants 93 participants 87 participants 89 participants 556 participants
Female
33
  33.7%
23
  25.3%
27
  27.6%
20
  21.5%
29
  33.3%
25
  28.1%
157
  28.2%
Male
65
  66.3%
68
  74.7%
71
  72.4%
73
  78.5%
58
  66.7%
64
  71.9%
399
  71.8%
1.Primary Outcome
Title The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
Hide Description FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.
Time Frame Baseline (prior to first dose) and Day 15 (24 hours after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.
Arm/Group Title Indacaterol 62.5 μg Indacaterol 125 μg Indacaterol 250 μg Indacaterol 500 μg Formoterol Placebo
Hide Arm/Group Description:
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Overall Number of Participants Analyzed 92 85 90 89 83 80
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.051  (0.0207) 0.073  (0.0217) 0.076  (0.0210) 0.121  (0.0211) 0.098  (0.0219) 0.005  (0.0223)
2.Secondary Outcome
Title Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose
Hide Description FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.
Time Frame Day 14, pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.
Arm/Group Title Indacaterol 62.5 μg Indacaterol 125 μg Indacaterol 250 μg Indacaterol 500 μg Formoterol Placebo
Hide Arm/Group Description:
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Overall Number of Participants Analyzed 93 86 90 89 83 81
Least Squares Mean (Standard Error)
Unit of Measure: liters
1.407  (0.0193) 1.461  (0.0202) 1.441  (0.0196) 1.500  (0.0198) 1.541  (0.0206) 1.315  (0.0208)
3.Secondary Outcome
Title The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1
Hide Description FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.
Time Frame Day 1 Baseline (prior to first dose) and 24 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.
Arm/Group Title Indacaterol 62.5 μg Indacaterol 125 μg Indacaterol 250 μg Indacaterol 500 μg Formoterol Placebo
Hide Arm/Group Description:
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Overall Number of Participants Analyzed 95 88 96 90 86 87
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.028  (0.0152) 0.054  (0.0158) 0.060  (0.0151) 0.073  (0.0156) 0.140  (0.0160) -0.009  (0.0160)
4.Secondary Outcome
Title Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1
Hide Description FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.
Time Frame Day 1; pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.
Arm/Group Title Indacaterol 62.5 μg Indacaterol 125 μg Indacaterol 250 μg Indacaterol 500 μg Formoterol Placebo
Hide Arm/Group Description:
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Overall Number of Participants Analyzed 98 91 97 91 87 87
Least Squares Mean (Standard Error)
Unit of Measure: liters
1.371  (0.0111) 1.422  (0.0116) 1.427  (0.0112) 1.438  (0.0116) 1.535  (0.0118) 1.321  (0.0118)
5.Secondary Outcome
Title Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14
Hide Description FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose.
Time Frame Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data, indicated by "N".
Arm/Group Title Indacaterol 62.5 μg Indacaterol 125 μg Indacaterol 250 μg Indacaterol 500 μg Formoterol Placebo
Hide Arm/Group Description:
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Overall Number of Participants Analyzed 98 91 98 93 87 89
Mean (Standard Deviation)
Unit of Measure: minutes
Day 1 [N=98, 91, 97, 91, 87, 87] 80.9  (76.01) 84.4  (77.74) 101.4  (83.44) 105.3  (81.85) 115.0  (81.59) 85.7  (81.44)
Day 14 [N=93, 86, 90, 89, 83, 82] 91.3  (81.20) 105.6  (82.53) 104.7  (75.96) 116.4  (85.03) 89.1  (72.91) 68.0  (70.38)
6.Secondary Outcome
Title Change From Baseline in Morning and Evening Peak Expiratory Flow
Hide Description The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling. Participants measured their PEF using a peak flow meter prior to taking study medication and recorded measurements in a diary every morning and evening during the study. Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14.
Time Frame Baseline (recorded during the screening period) and Days 1-14 (treatment period).
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. The analysis only includes patients with non-missing data.
Arm/Group Title Indacaterol 62.5 μg Indacaterol 125 μg Indacaterol 250 μg Indacaterol 500 μg Formoterol Placebo
Hide Arm/Group Description:
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Overall Number of Participants Analyzed 98 91 98 93 87 89
Mean (Standard Deviation)
Unit of Measure: liters/minute
Morning [N=56, 63, 59, 54, 54, 55] 3.10  (29.709) 19.91  (34.060) 23.63  (30.707) 11.11  (36.787) 16.06  (31.544) -4.24  (31.357)
Evening [N=56, 58, 56, 49, 48, 52] -2.72  (28.816) 13.42  (30.500) 19.00  (24.004) 5.92  (43.490) 14.97  (40.355) -2.75  (35.034)
7.Secondary Outcome
Title Number of Participants Using Rescue Medication
Hide Description Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period.
Time Frame Over 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Indacaterol 62.5 μg Indacaterol 125 μg Indacaterol 250 μg Indacaterol 500 μg Formoterol Placebo
Hide Arm/Group Description:
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
Overall Number of Participants Analyzed 98 91 98 93 87 89
Measure Type: Number
Unit of Measure: participants
Day 74 61 73 65 65 70
Night 72 60 67 59 67 72
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Indacaterol 62.5 μg Indacaterol 125 μg Indacaterol 250 μg Indacaterol 500 μg Formoterol Placebo
Hide Arm/Group Description Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
All-Cause Mortality
Indacaterol 62.5 μg Indacaterol 125 μg Indacaterol 250 μg Indacaterol 500 μg Formoterol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Indacaterol 62.5 μg Indacaterol 125 μg Indacaterol 250 μg Indacaterol 500 μg Formoterol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/98 (1.02%)   0/92 (0.00%)   1/101 (0.99%)   2/96 (2.08%)   1/90 (1.11%)   1/91 (1.10%) 
Nervous system disorders             
CEREBROVASCULAR ACCIDENT  1  0/98 (0.00%)  0/92 (0.00%)  0/101 (0.00%)  1/96 (1.04%)  0/90 (0.00%)  0/91 (0.00%) 
Psychiatric disorders             
CONFUSIONAL STATE  1  0/98 (0.00%)  0/92 (0.00%)  0/101 (0.00%)  1/96 (1.04%)  0/90 (0.00%)  0/91 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  1/98 (1.02%)  0/92 (0.00%)  1/101 (0.99%)  1/96 (1.04%)  1/90 (1.11%)  1/91 (1.10%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Indacaterol 62.5 μg Indacaterol 125 μg Indacaterol 250 μg Indacaterol 500 μg Formoterol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/98 (4.08%)   5/92 (5.43%)   3/101 (2.97%)   4/96 (4.17%)   6/90 (6.67%)   8/91 (8.79%) 
Infections and infestations             
NASOPHARYNGITIS  1  2/98 (2.04%)  0/92 (0.00%)  1/101 (0.99%)  1/96 (1.04%)  5/90 (5.56%)  2/91 (2.20%) 
Nervous system disorders             
HEADACHE  1  2/98 (2.04%)  5/92 (5.43%)  2/101 (1.98%)  3/96 (3.13%)  1/90 (1.11%)  6/91 (6.59%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00557466     History of Changes
Other Study ID Numbers: CQMF149B2201
First Submitted: November 13, 2007
First Posted: November 14, 2007
Results First Submitted: November 12, 2012
Results First Posted: January 18, 2013
Last Update Posted: January 18, 2013