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Study to Assess the Efficacy, Safety and Tolerability of LCQ908 in NAFLD Patients

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ClinicalTrials.gov Identifier: NCT01811472
Recruitment Status : Completed
First Posted : March 14, 2013
Results First Posted : February 4, 2016
Last Update Posted : February 4, 2016
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 Non-alcoholic Fatty Liver Disease (NAFLD)
Interventions Drug: LCQ908
Drug: placebo
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Pradigastat (LCQ908) 5mg/10mg Pradigastat (LCQ908) 10mg/20mg
Hide Arm/Group Description Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study. Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study. Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Period Title: Overall Study
Started 20 11 21
Completed 18 11 16
Not Completed 2 0 5
Reason Not Completed
Adverse Event             1             0             4
Lost to Follow-up             0             0             1
Subject/guardian decision             1             0             0
Arm/Group Title Placebo Pradigastat (LCQ908) 5mg/10mg Pradigastat (LCQ908) 10mg/20mg Total
Hide Arm/Group Description Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study. Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study. Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study. Total of all reporting groups
Overall Number of Baseline Participants 20 11 21 52
Hide Baseline Analysis Population Description
Full analysis set included patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Mis-randomized patients were those who were not qualified for randomization, but were inadvertently randomized into the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 11 participants 21 participants 52 participants
55.9  (7.69) 58.7  (6.56) 47.7  (11.76) 53.2  (10.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 11 participants 21 participants 52 participants
Female
10
  50.0%
6
  54.5%
10
  47.6%
26
  50.0%
Male
10
  50.0%
5
  45.5%
11
  52.4%
26
  50.0%
1.Primary Outcome
Title Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24
Hide Description Patients were to undergo MRI three times during the course of the study to assess liver fat. Baseline is defined as the value collected at Week -2 MRI assessment (approximately between Day -7 to -14).
Time Frame From baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with baseline and post-baseline value at week 24 are included in this analysis.
Arm/Group Title Placebo Pradigastat (LCQ908) 5mg/10mg Pradigastat (LCQ908) 10mg/20mg
Hide Arm/Group Description:
Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Overall Number of Participants Analyzed 19 10 17
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage of liver fat
0.00
(-1.63 to 1.63)
-1.68
(-3.93 to 0.56)
-2.89
(-4.59 to -1.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pradigastat (LCQ908) 5mg/10mg
Comments Hypothesis was tested at the 1-sided 5% significance level to assess if LCQ908 5mg/10mg was different from placebo.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The power calculation was largely driven by the maximum true response assumed in the candidate response shapes, which is a difference of −5.2% for pradigastat vs placebo for the primary endpoint.
Statistical Test of Hypothesis P-Value 0.3128
Comments [Not Specified]
Method Mixed Model of Repeated Measurements
Comments Degrees of freedom are adjusted using the Kenward-Roger method.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.69
Confidence Interval (2-Sided) 90%
-4.46 to 1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Pradigastat (LCQ908) 10mg/20mg
Comments Hypothesis was tested at the 1-sided 5% significance level to assess if LCQ908 10mg/20mg was different from placebo.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The power calculation was largely driven by the maximum true response assumed in the candidate response shapes, which is a difference of −5.2% for pradigastat vs placebo for the primary endpoint.
Statistical Test of Hypothesis P-Value 0.0457
Comments [Not Specified]
Method Mixed Model of Repeated Measurements
Comments Degrees of freedom are adjusted using the Kenward-Roger method.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.89
Confidence Interval (2-Sided) 90%
-5.25 to -0.53
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 12
Hide Description Patients were to undergo MRI three times during the course of the study to assess liver fat. Baseline is defined as the value collected at Week -2 MRI assessment (approximately between Day -7 to -14).
Time Frame From baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with baseline and post-baseline value at week 12 are included in this analysis.
Arm/Group Title Placebo Pradigastat (LCQ908) 5mg/10mg Pradigastat (LCQ908) 10mg/20mg
Hide Arm/Group Description:
Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Overall Number of Participants Analyzed 20 11 19
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Percentage of liver fat
-0.80
(-2.31 to 0.72)
-1.71
(-3.79 to 0.37)
-2.98
(-4.55 to -1.42)
3.Secondary Outcome
Title Percentage of Responders at Week 12
Hide Description

The response criteria are defined as:

a. A reduction of ≥ 30% from baseline in liver fat b. A reduction of ≥ 50% from baseline in liver fat c. Liver fat content < 10% d. Liver fat content < 5.6%. Percentage is calculated as (m/n)*100 where m: number of patients who are responders. n: number of patients with non-missing percent liver fat at that visit.

Time Frame At week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing percent liver fat at week 12 were included in this endpoint analysis.
Arm/Group Title Placebo Pradigastat (LCQ908) 5mg/10mg Pradigastat (LCQ908) 10mg/20mg
Hide Arm/Group Description:
Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Overall Number of Participants Analyzed 20 11 19
Measure Type: Number
Unit of Measure: Percentage of responders
At least 30% reduction in percent liver fat 10.00 18.18 31.58
At least 50% reduction in percent liver fat 5.00 0.00 21.05
Liver fat content < 10% 5.00 18.18 36.84
Liver fat content <5.6% 0.00 0.00 21.05
4.Secondary Outcome
Title Percentage of Responders at Week 24
Hide Description

The response criteria are defined as:

a. A reduction of ≥ 30% from baseline in liver fat b. A reduction of ≥ 50% from baseline in liver fat c. Liver fat content < 10% d. Liver fat content < 5.6%. Percentage is calculated as (m/n)*100 where m: number of patients who are responders. n: number of patients with non-missing percent liver fat at that visit.

Time Frame From baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing percent liver fat at week 24 were included in this endpoint analysis.
Arm/Group Title Placebo Pradigastat (LCQ908) 5mg/10mg Pradigastat (LCQ908) 10mg/20mg
Hide Arm/Group Description:
Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Overall Number of Participants Analyzed 19 10 17
Measure Type: Number
Unit of Measure: Percentage of responders
At least 30% reduction in percent liver fat 10.53 30.00 35.29
At least 50% reduction in percent liver fat 0.00 0.00 17.65
Liver fat content < 10% 5.26 20.00 52.94
Liver fat content <5.6% 0.00 0.00 17.65
5.Secondary Outcome
Title Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 6
Hide Description

Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).

Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate.

Time Frame From Baseline to week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at different timepoint were included in this endpoint analysis.
Arm/Group Title Placebo Pradigastat (LCQ908) 5mg/10mg Pradigastat (LCQ908) 10mg/20mg
Hide Arm/Group Description:
Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Overall Number of Participants Analyzed 20 11 20
Least Squares Mean (90% Confidence Interval)
Unit of Measure: U/L
Liver enzyme: Alanine aminotransferase (ALT)
-2.6
(-10.6 to 5.3)
1.4
(-9.2 to 12.1)
-9.1
(-17.0 to -1.1)
Liver enzyme: Aspartate aminotransferase (AST)
2.9
(-2.1 to 7.9)
4.7
(-2.0 to 11.5)
-2.5
(-7.5 to 2.5)
Liver enzyme: Gamma glutamyl transferase (GGT)
-13.9
(-22.1 to -5.7)
-7.0
(-18.1 to 4.0)
-0.9
(-9.1 to 7.3)
6.Secondary Outcome
Title Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 12
Hide Description

Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).

Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate.

Time Frame From Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at week 12 were included in this endpoint analysis.
Arm/Group Title Placebo Pradigastat (LCQ908) 5mg/10mg Pradigastat (LCQ908) 10mg/20mg
Hide Arm/Group Description:
Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Overall Number of Participants Analyzed 20 11 20
Least Squares Mean (90% Confidence Interval)
Unit of Measure: U/L
Liver enzyme: Alanine aminotransferase (ALT)
-0.6
(-10.3 to 9.1)
2.9
(-10.2 to 16.0)
-3.7
(-13.8 to 6.4)
Liver enzyme: Aspartate aminotransferase (AST)
5.7
(-0.9 to 12.3)
8.9
(0.0 to 17.7)
-0.1
(-7.1 to 6.9)
Liver enzyme: Gamma glutamyl transferase (GGT)
-0.4
(-21.5 to 20.8)
-6.0
(-34.4 to 22.5)
12.0
(-10.4 to 34.5)
7.Secondary Outcome
Title Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 24
Hide Description

Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).

Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate.

Time Frame From Baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at week 24 were included in this endpoint analysis.
Arm/Group Title Placebo Pradigastat (LCQ908) 5mg/10mg Pradigastat (LCQ908) 10mg/20mg
Hide Arm/Group Description:
Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Overall Number of Participants Analyzed 20 11 20
Least Squares Mean (90% Confidence Interval)
Unit of Measure: U/L
Liver enzyme: Alanine aminotransferase (ALT)
-5.3
(-12.4 to 1.8)
-1.0
(-10.4 to 8.3)
-10.0
(-17.5 to -2.5)
Liver enzyme: Aspartate aminotransferase (AST)
-1.8
(-7.9 to 4.3)
2.5
(-5.4 to 10.4)
-3.2
(-9.6 to 3.3)
Liver enzyme: Gamma glutamyl transferase (GGT)
-11.6
(-22.2 to -1.0)
-8.3
(-22.3 to 5.7)
0.1
(-11.1 to 11.3)
8.Secondary Outcome
Title Percentage of Patients With Normalized Liver Enzymes
Hide Description Normalized liver enzymes defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 40 U/L. Normal/High categories at baseline are defined by criteria of normal. Better is defined as high' at baseline and 'normal' post-dose; Same is defined as 'normal' at baseline and 'normal' post-dose or 'high' at baseline and 'high' post-dose; Worse is defined as 'normal' at baseline and 'high' post-dose.
Time Frame Baseline, week 6, week 12 and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at different timepoints were included in this endpoint analysis.
Arm/Group Title Placebo Pradigastat (LCQ908) 5mg/10mg Pradigastat (LCQ908) 10mg/20mg
Hide Arm/Group Description:
Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Overall Number of Participants Analyzed 20 11 20
Measure Type: Number
Unit of Measure: Percentage of patients
Better, week 6 10.0 0.0 10.0
Same, week 6 85.0 90.9 85.0
Worse, week 6 5.0 9.1 5.0
Better, week 12 5.0 9.1 17.6
Same, week 12 90.0 72.7 64.7
Worse, week 12 5.0 18.2 17.6
Better, week 24 5.3 18.2 17.6
Same, week 24 89.5 72.7 58.8
Worse, week 24 5.3 9.1 23.5
9.Secondary Outcome
Title Percent Change From Baseline in Fasting Triglycerides
Hide Description

Blood samples were collected for a fasting triglycerides (TG) after a 10-hour (overnight) fast.

Adjusted geometric means which is reported are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline. Baseline is defined as the value collected at Week 0 (randomization).

Time Frame Baseline, 6, 12 and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing values at different timepoints were included in this endpoint analysis
Arm/Group Title Placebo Pradigastat (LCQ908) 5mg/10mg Pradigastat (LCQ908) 10mg/20mg
Hide Arm/Group Description:
Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Overall Number of Participants Analyzed 20 11 21
Geometric Mean (90% Confidence Interval)
Unit of Measure: percent change
Change From Baseline to week 6 (n= 20,11, 20)
-14.6
(-26.5 to -0.8)
-16.0
(-31.3 to 2.8)
3.2
(-11.1 to 19.8)
Change From Baseline to week 12 (n = 20,11,17)
-7.3
(-18.2 to 5.2)
-7.9
(-22.3 to 9.1)
-15.8
(-26.5 to -3.5)
Change From Baseline to week 24 (n= 19,11,17)
13.0
(-3.8 to 32.6)
-10.0
(-27.3 to 11.3)
-2.4
(-17.6 to 15.5)
10.Secondary Outcome
Title Post-prandial Peak Triglycerides Over 0 - 8 Hours
Hide Description

Post-prandial peak triglycerides is reported as maximum triglyceride value over 0-8 hours.

Adjusted geometric means which is reported are calculated by back-transforming the adjusted means from the model. Baseline is defined as the value collected at Week 0 (randomization).

Time Frame Baseline, 6 and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing values at different timepoints were included in this endpoint analysis
Arm/Group Title Placebo Pradigastat (LCQ908) 5mg/10mg Pradigastat (LCQ908) 10mg/20mg
Hide Arm/Group Description:
Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Overall Number of Participants Analyzed 20 11 21
Geometric Mean (90% Confidence Interval)
Unit of Measure: mg/dL
Baseline (n= 20, 11, 21)
394.0
(364.8 to 425.5)
370.2
(333.8 to 410.6)
375.9
(348.8 to 405.1)
Week 6 (n = 20,11,20)
336.0
(296.8 to 380.4)
309.7
(262.1 to 366.0)
374.1
(330.7 to 423.3)
Week 24 (n= 20, 11, 15)
401.5
(346.6 to 465.0)
305.7
(205.9 to 372.5)
351.8
(299.0 to 378.9)
11.Secondary Outcome
Title Change From Baseline in Body Weight
Hide Description [Not Specified]
Time Frame Baseline, 12 and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with both baseline and post-baseline values at different timepoints were included in this endpoint analysis
Arm/Group Title Placebo Pradigastat (LCQ908) 5mg/10mg Pradigastat (LCQ908) 10mg/20mg
Hide Arm/Group Description:
Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Overall Number of Participants Analyzed 20 11 21
Least Squares Mean (90% Confidence Interval)
Unit of Measure: kilogram (kg)
Change from baseline to week 12 (n=20, 11, 17)
-1.3
(-2.0 to -0.5)
-2.2
(-3.2 to -1.2)
-2.4
(-3.2 to -1.6)
Change from baseline to week 24 (n=18, 11, 17)
-1.1
(-2.5 to 0.4)
-2.8
(-4.7 to -1.0)
-2.5
(-4.0 to -1.1)
12.Secondary Outcome
Title Change From Baseline in Waist Circumference
Hide Description [Not Specified]
Time Frame Baseline, 12 and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with both baseline and post-baseline values at different timepoints were included in this endpoint analysis
Arm/Group Title Placebo Pradigastat (LCQ908) 5mg/10mg Pradigastat (LCQ908) 10mg/20mg
Hide Arm/Group Description:
Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Overall Number of Participants Analyzed 20 11 21
Least Squares Mean (90% Confidence Interval)
Unit of Measure: centimeter (cm)
Change from baseline to week 12 (n=20, 11, 17)
-0.4
(-2.3 to 1.6)
-3.7
(-6.4 to -1.0)
-4.2
(-6.3 to -2.1)
Change from baseline to week 24 (n=19, 11, 17)
-1.7
(-3.9 to 0.6)
-3.7
(-6.7 to -0.6)
-4.2
(-6.6 to -1.9)
13.Secondary Outcome
Title Number of Patients With Adverse Events, Serious Adverse Events (SAEs) and Death as Assessment of Safety and Tolerability
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set (SAF) - All patients who received at least one dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Placebo Pradigastat (LCQ908) 5mg/10mg Pradigastat (LCQ908) 10mg/20mg
Hide Arm/Group Description:
Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Overall Number of Participants Analyzed 20 11 21
Measure Type: Number
Unit of Measure: Patients
Patients with any adverse event 14 9 20
Patients with at least one SAE 3 1 2
Death 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description Safety set (SAF) - All patients who received at least one dose of study drug and had at least 1 post-baseline safety assessment.
 
Arm/Group Title Placebo Pradigastat (LCQ908) 5mg /10 mg Pradigastat (LCQ908) 10mg/20 mg Pooled Pradigastat (LCQ908)
Hide Arm/Group Description Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study. Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study. Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study. This arm included all patients randomized to pradigastat (LCQ908) 5mg/10 mg and pradigastat (LCQ908)10mg/20 mg
All-Cause Mortality
Placebo Pradigastat (LCQ908) 5mg /10 mg Pradigastat (LCQ908) 10mg/20 mg Pooled Pradigastat (LCQ908)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Pradigastat (LCQ908) 5mg /10 mg Pradigastat (LCQ908) 10mg/20 mg Pooled Pradigastat (LCQ908)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/20 (15.00%)   1/11 (9.09%)   2/21 (9.52%)   3/32 (9.38%) 
General disorders         
NON-CARDIAC CHEST PAIN  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
Investigations         
ALANINE AMINOTRANSFERASE INCREASED  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
Musculoskeletal and connective tissue disorders         
INTERVERTEBRAL DISC PROTRUSION  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
LUMBAR SPINAL STENOSIS  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
Nervous system disorders         
LUMBAR RADICULOPATHY  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
SPINAL CLAUDICATION  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
SYNCOPE  1  0/20 (0.00%)  0/11 (0.00%)  1/21 (4.76%)  1/32 (3.13%) 
Psychiatric disorders         
DEPRESSION  1  0/20 (0.00%)  0/11 (0.00%)  1/21 (4.76%)  1/32 (3.13%) 
PANIC ATTACK  1  0/20 (0.00%)  0/11 (0.00%)  1/21 (4.76%)  1/32 (3.13%) 
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%
Placebo Pradigastat (LCQ908) 5mg /10 mg Pradigastat (LCQ908) 10mg/20 mg Pooled Pradigastat (LCQ908)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/20 (70.00%)   9/11 (81.82%)   20/21 (95.24%)   29/32 (90.63%) 
Blood and lymphatic system disorders         
ANISOCYTOSIS  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
Cardiac disorders         
PALPITATIONS  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
Eye disorders         
CONJUNCTIVITIS ALLERGIC  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
Gastrointestinal disorders         
ABDOMINAL DISCOMFORT  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
ABDOMINAL DISTENSION  1  3/20 (15.00%)  2/11 (18.18%)  3/21 (14.29%)  5/32 (15.63%) 
ABDOMINAL PAIN  1  3/20 (15.00%)  1/11 (9.09%)  10/21 (47.62%)  11/32 (34.38%) 
ABDOMINAL PAIN LOWER  1  0/20 (0.00%)  1/11 (9.09%)  2/21 (9.52%)  3/32 (9.38%) 
ABDOMINAL PAIN UPPER  1  4/20 (20.00%)  3/11 (27.27%)  3/21 (14.29%)  6/32 (18.75%) 
CONSTIPATION  1  4/20 (20.00%)  0/11 (0.00%)  3/21 (14.29%)  3/32 (9.38%) 
DEFAECATION URGENCY  1  1/20 (5.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
DIARRHOEA  1  7/20 (35.00%)  6/11 (54.55%)  18/21 (85.71%)  24/32 (75.00%) 
DYSPEPSIA  1  2/20 (10.00%)  3/11 (27.27%)  2/21 (9.52%)  5/32 (15.63%) 
ERUCTATION  1  0/20 (0.00%)  1/11 (9.09%)  2/21 (9.52%)  3/32 (9.38%) 
FAECES DISCOLOURED  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
FAECES HARD  1  2/20 (10.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
FAECES SOFT  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
FLATULENCE  1  4/20 (20.00%)  2/11 (18.18%)  3/21 (14.29%)  5/32 (15.63%) 
GASTROINTESTINAL MOTILITY DISORDER  1  3/20 (15.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
GASTROINTESTINAL SOUNDS ABNORMAL  1  4/20 (20.00%)  1/11 (9.09%)  1/21 (4.76%)  2/32 (6.25%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  1/20 (5.00%)  1/11 (9.09%)  1/21 (4.76%)  2/32 (6.25%) 
GINGIVAL PAIN  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
NAUSEA  1  3/20 (15.00%)  4/11 (36.36%)  11/21 (52.38%)  15/32 (46.88%) 
VOMITING  1  3/20 (15.00%)  2/11 (18.18%)  3/21 (14.29%)  5/32 (15.63%) 
General disorders         
CHILLS  1  0/20 (0.00%)  0/11 (0.00%)  2/21 (9.52%)  2/32 (6.25%) 
INFLUENZA LIKE ILLNESS  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
Infections and infestations         
BRONCHITIS  1  0/20 (0.00%)  1/11 (9.09%)  2/21 (9.52%)  3/32 (9.38%) 
LYME DISEASE  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
NASOPHARYNGITIS  1  4/20 (20.00%)  2/11 (18.18%)  0/21 (0.00%)  2/32 (6.25%) 
PHARYNGITIS STREPTOCOCCAL  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
RESPIRATORY TRACT INFECTION  1  1/20 (5.00%)  0/11 (0.00%)  1/21 (4.76%)  1/32 (3.13%) 
UPPER RESPIRATORY TRACT INFECTION  1  1/20 (5.00%)  2/11 (18.18%)  0/21 (0.00%)  2/32 (6.25%) 
URINARY TRACT INFECTION  1  0/20 (0.00%)  2/11 (18.18%)  0/21 (0.00%)  2/32 (6.25%) 
Injury, poisoning and procedural complications         
CONTUSION  1  2/20 (10.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
FALL  1  1/20 (5.00%)  0/11 (0.00%)  1/21 (4.76%)  1/32 (3.13%) 
INCISION SITE PAIN  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
LACERATION  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
LIGAMENT SPRAIN  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
STRESS FRACTURE  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
Investigations         
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
RETICULOCYTE COUNT INCREASED  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
Metabolism and nutrition disorders         
DECREASED APPETITE  1  0/20 (0.00%)  2/11 (18.18%)  0/21 (0.00%)  2/32 (6.25%) 
HYPOKALAEMIA  1  1/20 (5.00%)  0/11 (0.00%)  1/21 (4.76%)  1/32 (3.13%) 
TYPE 2 DIABETES MELLITUS  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  1/20 (5.00%)  0/11 (0.00%)  1/21 (4.76%)  1/32 (3.13%) 
BACK PAIN  1  2/20 (10.00%)  0/11 (0.00%)  2/21 (9.52%)  2/32 (6.25%) 
FLANK PAIN  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
INTERVERTEBRAL DISC DEGENERATION  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
INTERVERTEBRAL DISC PROTRUSION  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
JOINT SWELLING  1  1/20 (5.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
LUMBAR SPINAL STENOSIS  1  1/20 (5.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
MUSCLE SPASMS  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
MUSCULOSKELETAL PAIN  1  1/20 (5.00%)  1/11 (9.09%)  2/21 (9.52%)  3/32 (9.38%) 
MYALGIA  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
OSTEOARTHRITIS  1  0/20 (0.00%)  2/11 (18.18%)  1/21 (4.76%)  3/32 (9.38%) 
PAIN IN EXTREMITY  1  1/20 (5.00%)  1/11 (9.09%)  1/21 (4.76%)  2/32 (6.25%) 
SPINAL OSTEOARTHRITIS  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
Nervous system disorders         
DIZZINESS  1  2/20 (10.00%)  1/11 (9.09%)  1/21 (4.76%)  2/32 (6.25%) 
HEADACHE  1  1/20 (5.00%)  4/11 (36.36%)  1/21 (4.76%)  5/32 (15.63%) 
HYPOAESTHESIA  1  2/20 (10.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
LUMBAR RADICULOPATHY  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
MIGRAINE  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
Psychiatric disorders         
ANXIETY  1  1/20 (5.00%)  0/11 (0.00%)  2/21 (9.52%)  2/32 (6.25%) 
INSOMNIA  1  0/20 (0.00%)  0/11 (0.00%)  2/21 (9.52%)  2/32 (6.25%) 
Renal and urinary disorders         
HAEMATURIA  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
NEPHROLITHIASIS  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
URINE ODOUR ABNORMAL  1  1/20 (5.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
Reproductive system and breast disorders         
MENOPAUSAL SYMPTOMS  1  0/20 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  1/32 (3.13%) 
Respiratory, thoracic and mediastinal disorders         
ASTHMA  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
COUGH  1  1/20 (5.00%)  0/11 (0.00%)  3/21 (14.29%)  3/32 (9.38%) 
DYSPNOEA EXERTIONAL  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
NASAL CONGESTION  1  1/20 (5.00%)  0/11 (0.00%)  1/21 (4.76%)  1/32 (3.13%) 
OROPHARYNGEAL PAIN  1  0/20 (0.00%)  1/11 (9.09%)  1/21 (4.76%)  2/32 (6.25%) 
PRODUCTIVE COUGH  1  0/20 (0.00%)  1/11 (9.09%)  1/21 (4.76%)  2/32 (6.25%) 
PULMONARY MASS  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
SLEEP APNOEA SYNDROME  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
Skin and subcutaneous tissue disorders         
RASH  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
Vascular disorders         
HYPERTENSION  1  1/20 (5.00%)  0/11 (0.00%)  0/21 (0.00%)  0/32 (0.00%) 
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 or disclosure of trial results in their entirety.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01811472     History of Changes
Other Study ID Numbers: CLCQ908A2216
2013-000049-38 ( EudraCT Number )
First Submitted: March 12, 2013
First Posted: March 14, 2013
Results First Submitted: September 8, 2015
Results First Posted: February 4, 2016
Last Update Posted: February 4, 2016