Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01609478
First received: April 23, 2012
Last updated: August 27, 2014
Last verified: August 2014

April 23, 2012
August 27, 2014
August 2012
July 2013   (final data collection date for primary outcome measure)
Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85) [ Time Frame: after 12 weeks (Day 85) ] [ Designated as safety issue: No ]
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 12 weeks (Day 85)
Trough Forced Expiratory Volume in one second (FEV1) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings.
Complete list of historical versions of study NCT01609478 on ClinicalTrials.gov Archive Site
  • Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85) [ Time Frame: aftert 12 weeks (Day 85) ] [ Designated as safety issue: No ]
    The Asthma Control Questionnaire (ACQ-5) is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.
  • Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment. [ Time Frame: Day 15, Day 29 and Day 57 ] [ Designated as safety issue: No ]
    Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 2 weeks (Day 15), 4 weeks (Day 29), and 8 weeks (Day 57) of treatment.
  • Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points [ Time Frame: Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 ] [ Designated as safety issue: No ]
    Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. FVC is measured on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at all time points
  • Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 [ Time Frame: Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 ] [ Designated as safety issue: No ]
    Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards.
  • Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 [ Time Frame: Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 ] [ Designated as safety issue: No ]
    Forced Expiratory Flow (FEF 25-75%) was measured via spirometry conducted according to internationally accepted standards.
  • Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84) [ Time Frame: Day 1, 2 Weeks, 12 Weeks ] [ Designated as safety issue: No ]
    Forced Expiratory Volume in 1 second (FEV1)/Area Under the Curve(AUC) was measured via spirometry conducted according to internationally accepted standards.FEV1 AUC(5 min - 4 h), (5 min - 1 h) and (1 h - 4 h) are measured at Day 1, 2 Weeks (Day 14) and 12 Weeks (Day84) and defined as average of FEV1 at specified timepoints above.
  • Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84) [ Time Frame: Day 1, 2 weeks (Day 14), 12 weeks (Day 84) ] [ Designated as safety issue: No ]
    Peak Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Peak FEV1 is defined as the maximum FEV1 during the first 4 h post morning dosing at Day 1, 2Weeks and 12 Weeks.
  • Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment [ Time Frame: after 4 weeks (Day 29) and after 8 weeks (Day 57) ] [ Designated as safety issue: No ]
    The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
  • Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period. [ Time Frame: baseline, 4weeks, 8 weeks and 12 weeks ] [ Designated as safety issue: No ]
    PEFR is measured with portable spirometer by participants every morning and evening at home.
  • The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Participants record the number of puffs of rescue medication taken in the previous 12 hours in the morning and nighttime.
  • Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment [ Time Frame: 4 Weeks, 12 Weeks ] [ Designated as safety issue: No ]
    The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.
  • Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Duration of treatment until first asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is systemic corticosteroids (SCS) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
  • The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations. Number of the asthma exacerbation will be analyzed by the negative binomial regression including treatment, history of asthma exacerbation in the 12 months prior to screening and region as factors and FEV1 prior to inhalation and FEV1 30 min post inhalation of salbutamol/albuterol (components of SABA reversibility) as covariates. The estimates are obtained from the model and so we cannot specify a formula.
  • Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Duration of asthma exacerbations by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
  • The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The percentage of patients with at least one asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
  • Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Time to permanent study discontinuation due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
  • The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The percentage of patients who permanently discontinued study due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
  • Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Total amounts (in doses) of systemic corticosteroids (SCS) used to treat asthma exacerbations.SCS includes Intramuscular (IM), Intravenous (IV) and Oral. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
  • Plasma Indacaterol Concentrations at Day 1 and Day 14 [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]
    Maximum plasma concentration after drug administration (Cmax) was measured for indacaterol acetate 75 µg and indacaterol acetate 150 µg for Pharmacokinetic (PK) Subgroup
  • Asthma Control Questionnaire 5 (ACQ-5) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze.

    Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).

  • Trough FEV1 [ Time Frame: 2 weeks, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
    Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 50 minute and 15 minute pre dose FEV1 readings for 4 weeks and as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings for 2weeks and 8weeks.
  • Forced vital capacity (FVC) at each timepoint [ Time Frame: Day 1, Day 2, Day 14, Day 15, Day 29, Day 57, Day 84, Day 85 ] [ Designated as safety issue: No ]
    Spirometry is conducted according to the global standard. FVC is measured at pre-dose and post dose up to 6 hour on Day 1, Day 14 and Day 84, at post dose 23 hour 10 minute and 23 hour 45 minutes on Day 2, Day 15 and Day 85, and at pre-dose 50 min and 15 min on Day 29 and Day 57.
  • FEV1/FVC at each timepoint [ Time Frame: Day 1, Day 2, Day 14, Day 15, Day 29, Day 57, Day 84, Day 85 ] [ Designated as safety issue: No ]
    Spirometry is conducted according to the global standard. FVC is measured at pre-dose and post dose up to 6 hour on Day 1, Day 14 and Day 84, at post dose 23 hour 10 minute and 23 hour 45 minutes on Day 2, Day 15 and Day 85, and at pre-dose 50 min and 15 min on Day 29 and Day 57.
  • Standardized FEV1 AUC(5 min - 4 h), (5 min - 1 h) and (1 h - 4 h) [ Time Frame: Day 1, 2 Weeks, 12 Weeks ] [ Designated as safety issue: No ]
    Spirometry is conducted according to the global standard. FEV1 AUC(5 min - 4 h), (5 min - 1 h) and (1 h - 4 h) are measured at Day 1 and 2 Weeks and 12 Weeks and defined as average of FEV1 at specified timepoints above.
  • Peak FEV1 [ Time Frame: Day 1, 2 Weeks, 12 Weeks ] [ Designated as safety issue: No ]
    Spirometry is conducted according to the global standard. Peak FEV1 is defined as the maximum FEV1 during the first 4 h post morning dosing at Day 1, 2Weeks and 12 Weeks.
  • Asthma Control Questionnaire 5 (ACQ-5) [ Time Frame: 4 Weeks, 8 Weeks ] [ Designated as safety issue: No ]

    The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze.

    Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).

  • Morning and evening peak expiratory flow rate (PEFR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    PEFR is measured with portable spirometer by participants every morning and evening at home.
  • The usage of rescue medication (short acting β2-agonist) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Participants record the number of puffs of rescue medication taken in the previous 12 hours in the morning and evening.
  • Asthma Quality of Life Questionnaire (AQLQ(S)) [ Time Frame: 4 Weeks, 12 Weeks ] [ Designated as safety issue: No ]
    The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.
  • Adverse events, laboratory analysis, vital signs and ECG [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Adverse event, laboratory tests (haematology, clinical chemistry and urinalysis), vital signs (i.e. blood pressure, pulse rate), and ECG (e.g. quantitative assessments - heart rate, QTc, PRS, PR intervals).
  • Plasma Indacaterol concentrations [ Time Frame: Day 1, Day 14 ] [ Designated as safety issue: Yes ]
    Indacaterol concentrations will be measured from pre-dose to 23h25min post -dose on Day 1 and Day 14.
  • Time to first asthma exacerbation (mild, moderate, severe, moderate or severe and any) during the 12 week treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Duration of treatment until first asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is systemic corticosteroids (SCS) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
  • The annual rate of asthma exacerbations (mild, moderate, severe, moderate or severe and any) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
  • Duration of asthma exacerbations (mild, moderate, severe, moderate or severe and any) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Duration of asthma exacerbations by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
  • The percentage of patients with at least one asthma exacerbation (mild, moderate, severe, moderate or severe and any) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The percentage of patients with at least one asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
  • Time to permanent study discontinuation due to asthma exacerbation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Time to permanent study discontinuation due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
  • The percentage of patients who permanently discontinued study due to asthma exacerbation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The percentage of patients who permanently discontinued study due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
  • Total amounts (in doses) of systemic corticosteroids used to treat asthma exacerbations. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Total amounts (in doses) of systemic corticosteroids used to treat asthma exacerbations. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
Not Provided
Not Provided
 
Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma
A Multicenter, Randomized, Double-blind, Placebo-controlled, 12-week Treatment, Parallel-group Study to Assess the Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate (75 and 150 µg o.d.) in Patients With Persistent Asthma

To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: indacaterol
    indacaterol acetate 150 µg indacaterol delivered via Concept 1 inhaler
  • Drug: placebo
    placebo delivered via Concept 1 inhaler
  • Drug: mometasone furoate
    via Twisthaler inhaler
  • Experimental: indacaterol acetate 75 µg

    indacaterol acetate 75 µg od delivered via Concept 1 inhaler

    Background therapy: mometasone furoate 200 mcg od

    Interventions:
    • Drug: indacaterol
    • Drug: mometasone furoate
  • Experimental: indacaterol acetate 150 µg

    indacaterol acetate 150 µg od delivered via Concept 1 inhaler

    Background therapy: mometasone furoate 200 mcg od

    Interventions:
    • Drug: indacaterol
    • Drug: mometasone furoate
  • Placebo Comparator: placebo

    placebo delivered via Concept 1 inhaler

    Background therapy: mometasone furoate 200 mcg od

    Interventions:
    • Drug: placebo
    • Drug: mometasone furoate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:
  • Patients who are receiving ICS treatment in a stable regimen for ≥ 4 weeks
  • Patients with a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% of predicted normal value
  • Patients who demonstrate an increase of >= 12% and 200 mL in FEV1
  • ACQ-5 score ≥ 1.5

Exclusion Criteria:

  • Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
  • Patients with chronic lung disease, including COPD, pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disease and cystic fibrosis.
  • Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.

Other protocol-defined inclusion/exclusion criteria may apply

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Canada,   Germany,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Slovakia
 
NCT01609478
CQMF149E2203, 2012-000520-18
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP