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Trial record 26 of 318 for:    FLUTICASONE AND SALMETEROL

QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) (ILLUMINATE)

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ClinicalTrials.gov Identifier: NCT01315249
Recruitment Status : Completed
First Posted : March 15, 2011
Results First Posted : August 9, 2013
Last Update Posted : August 9, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease (COPD)
Interventions Drug: indacaterol and glycopyrronium (QVA149)
Drug: Placebo to fluticasone/salmeterol
Drug: fluticasone/salmeterol
Drug: Placebo to indacaterol and glycopyrronium (QVA149)
Enrollment 523
Recruitment Details All eligible patients were randomized to one of the 2 arms in a 1:1 ratio for 26 weeks of treatment.
Pre-assignment Details A total of 523 patients were randomized. A total of 522 patients (99.8%) were included in the Full analysis Set (FAS) and Safety set. One patient was excluded who was randomized in error and did not receive study medication.
Arm/Group Title QVA149 Fluticasone/Salmeterol
Hide Arm/Group Description Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol. Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
Period Title: Overall Study
Started 259 264
Completed 215 217
Not Completed 44 47
Reason Not Completed
Adverse Event             22             26
Withdrawal by Subject             11             10
Protocol Violation             8             5
Abnormal test results             1             2
Administrative problems             1             0
inability to use device             1             0
Lack of Efficacy             0             1
Lost to Follow-up             0             2
Death             0             1
Arm/Group Title QVA149 Fluticasone/Salmeterol Total
Hide Arm/Group Description Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol. Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149). Total of all reporting groups
Overall Number of Baseline Participants 258 264 522
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 258 participants 264 participants 522 participants
63.2  (8.16) 63.4  (7.71) 63.3  (7.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants 264 participants 522 participants
Female
77
  29.8%
75
  28.4%
152
  29.1%
Male
181
  70.2%
189
  71.6%
370
  70.9%
1.Primary Outcome
Title Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12
Hide Description Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.
Arm/Group Title QVA149 Fluticasone/Salmeterol
Hide Arm/Group Description:
Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
Overall Number of Participants Analyzed 212 216
Least Squares Mean (Standard Error)
Unit of Measure: liters
1.69  (0.027) 1.56  (0.026)
2.Secondary Outcome
Title Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours
Hide Description Standardized Forced Expiratory Volume in 1 Second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were made between 0 and 12 hours after treatment. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 12. Results are obtained from linear mixed model.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.
Arm/Group Title QVA149 Fluticasone/Salmeterol
Hide Arm/Group Description:
Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
Overall Number of Participants Analyzed 255 261
Least Squares Mean (Standard Error)
Unit of Measure: liters
1.71  (0.023) 1.59  (0.022)
3.Secondary Outcome
Title Forced Vital Capacity at All-time Points (Week 12)
Hide Description

Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.

This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose week 12. Results are obtained from linear mixed model.

Time Frame -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.
Arm/Group Title QVA149 Fluticasone/Salmeterol
Hide Arm/Group Description:
Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
Overall Number of Participants Analyzed 230 237
Least Squares Mean (Standard Error)
Unit of Measure: liters
-45 minutes (n=230 QVA149; 237 flut/salm) 3.37  (0.046) 3.16  (0.044)
-15 minutes (n=228 QVA149; 235 flut/salm) 3.37  (0.047) 3.17  (0.045)
5 minutes (n=229 QVA149; 236 flut/salm) 3.44  (0.048) 3.20  (0.046)
30 minutes (n=229 QVA149; 235 flut/salm) 3.48  (0.048) 3.23  (0.046)
1 hour (n=228 QVA149; 236 flut/salm) 3.49  (0.049) 3.26  (0.047)
2 hours (n=229 QVA149; 237 flut/salm) 3.54  (0.048) 3.31  (0.046)
4 hours (n=228 QVA149; 237 flut/salm) 3.49  (0.050) 3.33  (0.048)
8 hours (n=228 QVA149; 237 flut/salm) 3.46  (0.048) 3.27  (0.046)
12 hours (n=228 QVA149; 236 flut/salm) 3.45  (0.050) 3.26  (0.049)
4.Secondary Outcome
Title Forced Vital Capacity at All-time Points (Week 26)
Hide Description

Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.

This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26. Results are obtained from linear mixed model.

Time Frame -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.
Arm/Group Title QVA149 Fluticasone/Salmeterol
Hide Arm/Group Description:
Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
Overall Number of Participants Analyzed 213 216
Least Squares Mean (Standard Error)
Unit of Measure: liters
-45 minutes (n=213 QVA149; 216 flut/salm) 3.32  (0.047) 3.13  (0.045)
-15 minutes (n=213 QVA149; 215 flut/salm) 3.33  (0.044) 3.12  (0.043)
5 minutes (n=212 QVA149; 215 flut/salm) 3.42  (0.051) 3.17  (0.049)
30 minutes (n=212 QVA149; 214 flut/salm) 3.47  (0.053) 3.23  (0.051)
1 hour (n=212 QVA149; 216 flut/salm) 3.50  (0.051) 3.23  (0.049)
2 hours (n=212 QVA149; 216 flut/salm) 3.51  (0.051) 3.29  (0.049)
4 hours (n=212 QVA149; 215 flut/salm) 3.45  (0.053) 3.28  (0.050)
8 hours (n=212 QVA149; 216 flut/salm) 3.40  (0.053) 3.21  (0.050)
12 hours (n=211 QVA149; 213 flut/salm) 3.40  (0.053) 3.18  (0.051)
5.Secondary Outcome
Title Focal Score of the Transitional Dyspnea Index (TDI)
Hide Description Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement.
Time Frame 12 weeks and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.
Arm/Group Title QVA149 Fluticasone/Salmeterol
Hide Arm/Group Description:
Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
Overall Number of Participants Analyzed 224 236
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 weeks (n=224 QVA149; 236 flut/salm) 2.03  (0.388) 1.45  (0.374)
26 weeks (n=212 QVA149; 213 flut/salm) 2.36  (0.388) 1.60  (0.376)
6.Secondary Outcome
Title Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)
Hide Description The total score of the St. George's Respiratory Questionnaire (SGRQ-C) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.
Time Frame 12 weeks and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.
Arm/Group Title QVA149 Fluticasone/Salmeterol
Hide Arm/Group Description:
Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
Overall Number of Participants Analyzed 230 238
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 weeks (n=230 QVA149; 238 flut/salm) 36.74  (1.175) 36.03  (1.132)
26 weeks (n=211 QVA149; 216 flut/salm) 35.45  (1.448) 36.68  (1.386)
7.Secondary Outcome
Title Mean Change From Baseline in Daily Number of Puffs of Rescue Medication
Hide Description Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.
Time Frame Baseline, 12 weeks and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.
Arm/Group Title QVA149 Fluticasone/Salmeterol
Hide Arm/Group Description:
Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
Overall Number of Participants Analyzed 253 259
Least Squares Mean (Standard Error)
Unit of Measure: puffs
Weeks 1 to12 -2.18  (0.187) -1.90  (0.184)
Weeks 1 to 26 -2.32  (0.194) -1.93  (0.191)
8.Secondary Outcome
Title Change From Baseline in Symptom Scores Reported Using the Ediary
Hide Description

Participants maintained an ediary to record daily symptom scores (AM and PM) over 12 weeks and 26 weeks of treatment. This analysis compares the mean symptom scores over 12 weeks and 26 weeks compared to baseline. The diary records morning and evening daily clinical symptoms including cough, wheezing, shortness of breath, sputum volume, sputum purulence, night time awakenings and rescue medication use.

Scale ranges: ranges are 0 to 3 with varying scale descriptions that pertain to the question being asked.

0 is the minimum score = “none” or “No symptoms” or “never” or “No”

  1. = mild, a little
  2. = moderate
  3. = severe For the scale range provided, high values represent a worse outcome.
Time Frame 12 weeks and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.
Arm/Group Title QVA149 Fluticasone/Salmeterol
Hide Arm/Group Description:
Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
Overall Number of Participants Analyzed 253 259
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Weeks 1-12 -1.08  (0.135) -1.17  (0.133)
Weeks 1-26 -1.28  (0.140) -1.24  (0.138)
9.Secondary Outcome
Title Inspiratory Capacity (IC) at All-time Points (12 Weeks)
Hide Description After 12 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Inspiratory capacity was measured for a subset of patients QVA149 group: (78 patients (30.2%)) at baseline and 49-73 patients contributing observations at post-baseline visits.

flut/salm group: (86 patients (32.6%)) at baseline and 60-79 patients contributing observations at post-baseline visits.

Arm/Group Title QVA149 Fluticasone/Salmeterol
Hide Arm/Group Description:
Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
Overall Number of Participants Analyzed 58 72
Least Squares Mean (Standard Error)
Unit of Measure: Liters
-20 minutes (n=51 QVA149; 65 flut/salm) 2.39  (0.081) 2.31  (0.073)
25 minutes (n=56 QVA149; 71 flut/salm) 2.55  (0.075) 2.42  (0.068)
1 hour (n=59 QVA149; 68 flut/salm) 2.54  (0.079) 2.43  (0.072)
3 hours (n=54 QVA149; 67 flut/salm) 2.52  (0.086) 2.45  (0.079)
7 hours (n=58 QVA149; 67 flut/salm) 2.42  (0.080) 2.41  (0.073)
11 hours (n=49 QVA149; 72 flut/salm) 2.40  (0.079) 2.34  (0.070)
10.Secondary Outcome
Title Inspiratory Capacity (IC) at All-time Points (26 Weeks)
Hide Description After 26 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Inspiratory capacity was measured for a subset of patients QVA149 group: (78 patients (30.2%)) at baseline and 49-73 patients contributing observations at post-baseline visits.

flut/salm group: (86 patients (32.6%)) at baseline and 60-79 patients contributing observations at post-baseline visits.

Arm/Group Title QVA149 Fluticasone/Salmeterol
Hide Arm/Group Description:
Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
Overall Number of Participants Analyzed 58 66
Least Squares Mean (Standard Error)
Unit of Measure: Liters
-20 minutes (n=53 QVA149; 63 flut/salm) 2.25  (0.079) 2.22  (0.071)
25 minutes (n=58 QVA149; 63 flut/salm) 2.41  (0.088) 2.34  (0.080)
1 hour (n=53 QVA149; 63 flut/salm) 2.38  (0.087) 2.35  (0.079)
3 hours (n=52 QVA149; 60 flut/salm) 2.33  (0.090) 2.32  (0.080)
7 hours (n=56 QVA149; 61 flut/salm) 2.40  (0.82) 2.30  (0.075)
11 hours (n=57 QVA149; 66 flut/salm) 2.37  (0.084) 2.27  (0.075)
11.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description The assessment of safety was based on Adverse Events. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Section.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set includes all participants who received at least one dose of study drug.
Arm/Group Title QVA149 Fluticasone/Salmeterol
Hide Arm/Group Description:
Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
Overall Number of Participants Analyzed 258 264
Measure Type: Number
Unit of Measure: participants
Any Adverse Event 143 159
Death 0 1
Serious Adverse Events 13 14
Discontinued due to Adverse Events 22 27
Discontinued due to Serious Adverse Events 5 9
Discontinued due to non-Serious Adverse Events 17 18
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title QVA149 Fluticasone/Salmeterol
Hide Arm/Group Description Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol. Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
All-Cause Mortality
QVA149 Fluticasone/Salmeterol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
QVA149 Fluticasone/Salmeterol
Affected / at Risk (%) Affected / at Risk (%)
Total   13/258 (5.04%)   14/264 (5.30%) 
Cardiac disorders     
Acute coronary syndrome  1  0/258 (0.00%)  1/264 (0.38%) 
Acute myocardial infarction  1  1/258 (0.39%)  0/264 (0.00%) 
Angina pectoris  1  1/258 (0.39%)  0/264 (0.00%) 
Atrial fibrillation  1  1/258 (0.39%)  0/264 (0.00%) 
Coronary artery stenosis  1  1/258 (0.39%)  0/264 (0.00%) 
Gastrointestinal disorders     
Dyspepsia  1  1/258 (0.39%)  0/264 (0.00%) 
Dysphagia  1  1/258 (0.39%)  0/264 (0.00%) 
Infections and infestations     
Abscess limb  1  0/258 (0.00%)  1/264 (0.38%) 
Bronchitis  1  0/258 (0.00%)  1/264 (0.38%) 
Nasopharyngitis  1  0/258 (0.00%)  1/264 (0.38%) 
Pneumonia  1  0/258 (0.00%)  2/264 (0.76%) 
Injury, poisoning and procedural complications     
Contusion  1  1/258 (0.39%)  0/264 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  1/258 (0.39%)  0/264 (0.00%) 
Musculoskeletal and connective tissue disorders     
Myopathy  1  1/258 (0.39%)  0/264 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer  1  0/258 (0.00%)  1/264 (0.38%) 
Lung adenocarcinoma  1  0/258 (0.00%)  1/264 (0.38%) 
Oesophageal carcinoma  1  1/258 (0.39%)  0/264 (0.00%) 
Rectal cancer  1  1/258 (0.39%)  0/264 (0.00%) 
Small cell lung cancer stage unspecified  1  0/258 (0.00%)  1/264 (0.38%) 
Nervous system disorders     
Carotid artery occlusion  1  0/258 (0.00%)  1/264 (0.38%) 
Carotid artery stenosis  1  1/258 (0.39%)  0/264 (0.00%) 
Ischaemic stroke  1  0/258 (0.00%)  1/264 (0.38%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/258 (0.39%)  0/264 (0.00%) 
Epididymitis  1  0/258 (0.00%)  1/264 (0.38%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/258 (0.39%)  0/264 (0.00%) 
Chronic obstructive pulmonary disease  1  1/258 (0.39%)  3/264 (1.14%) 
Dyspnoea  1  1/258 (0.39%)  0/264 (0.00%) 
Pleural effusion  1  1/258 (0.39%)  1/264 (0.38%) 
Skin and subcutaneous tissue disorders     
Skin ulcer  1  0/258 (0.00%)  1/264 (0.38%) 
Vascular disorders     
Peripheral artery aneurysm  1  0/258 (0.00%)  1/264 (0.38%) 
Venous insufficiency  1  0/258 (0.00%)  1/264 (0.38%) 
Venous thrombosis limb  1  1/258 (0.39%)  0/264 (0.00%) 
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%
QVA149 Fluticasone/Salmeterol
Affected / at Risk (%) Affected / at Risk (%)
Total   73/258 (28.29%)   82/264 (31.06%) 
Infections and infestations     
Nasopharyngitis  1  37/258 (14.34%)  29/264 (10.98%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  44/258 (17.05%)  60/264 (22.73%) 
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis
Phone: 41 61 324 1111
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01315249     History of Changes
Other Study ID Numbers: CQVA149A2313
2010-023621-37 ( EudraCT Number )
First Submitted: March 11, 2011
First Posted: March 15, 2011
Results First Submitted: February 28, 2013
Results First Posted: August 9, 2013
Last Update Posted: August 9, 2013