Trial · NCT01589237
Extension to a Randomized, Double-blind, Placebo Controlled Study of LCQ908 in Subjects With Familial Chylomicronemia Syndrome.
NCT01589237, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2016-11-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Extension to a Randomized, Double-blind, Placebo Controlled Study of LCQ908 in Subjects With Familial Chylomicronemia Syndrome. Trials, record NCT01589237. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01589237
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension to a Randomized, Double-blind, Placebo Controlled Study of LCQ908 in Subjects With Familial Chylomicronemia Syndrome.
- NCT number
- NCT01589237
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 38 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Familial Chylomicronemia Syndrome (FCS) (HLP Type I)
- Interventions
- LCQ908
- First posted
- 2012-05-01
- Last updated
- 2016-11-15
- Other registries' IDs
- eudract:2012-000802-32
- Results first posted
- 2016-11-15
- Limitations and caveats
As the anticipated benefit from the continued participation of patients in 18 month extension (Part B) was not supported by results of the December 2014 interim analysis, Novartis decided to terminate the Part B to be effective as of May 31, 2015.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Any Adverse Events, Serious Adverse Events and Death | 52 weeks | |
| Secondary | Changes From Baseline in Triglyceride Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Blood samples were collected for a fasting lipid panel, including total triglycerides. Lipid measurements were collected after a 12 hour (overnight) fast. The maintenance of effect was assessed on triglyceride levels during continued therapy with LCQ908 for up to 52 weeks. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100. |
| Secondary | Changes From Baseline in Cholesterol Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Blood samples were collected for a fasting lipid panel, including cholesterol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100. |
| Secondary | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Blood samples were collected for a fasting lipid panel, including HDL and non HDL cholesterol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100. |
| Secondary | Changes From Baseline in Glycerol Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Blood samples were collected for a fasting lipid panel, including glycerol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100. |
| Secondary | Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Blood samples were collected for a fasting lipid panel, including free fatty acid level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100. |
| Secondary | Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein A1. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100. |
| Secondary | Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein B-48. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100. |
| Secondary | Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein B-100. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Any Adverse Events, Serious Adverse Events and Death | 52 weeks | Safety set (SAF) - All subjects who received at least one dose of study drug and had at least one post-baseline safety assessment in this extension study. | Participants | NUMBER |
| SECONDARY | Changes From Baseline in Triglyceride Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included. | percentage change | GEOMETRIC_MEAN |
| SECONDARY | Changes From Baseline in Cholesterol Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included. | percentage change | GEOMETRIC_MEAN |
| SECONDARY | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included. | percentage change | GEOMETRIC_MEAN |
| SECONDARY | Changes From Baseline in Glycerol Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included. | percentage change | GEOMETRIC_MEAN |
| SECONDARY | Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included. | percentage change | GEOMETRIC_MEAN |
| SECONDARY | Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included. | percentage change | GEOMETRIC_MEAN |
| SECONDARY | Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included. | percentage change | GEOMETRIC_MEAN |
| SECONDARY | Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included. | percentage change | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group120
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Any Adverse Events, Serious Adverse Events and Death | Placebo of Pradigastat (LCQ908) Regimen | At least one Adverse Event (any) | 11 | Participants | |
| Number of Patients With Any Adverse Events, Serious Adverse Events and Death | 20 mg Pradigastat (LCQ908) Regimen | At least one Adverse Event (any) | 12 | Participants | |
| Number of Patients With Any Adverse Events, Serious Adverse Events and Death | 40 mg Pradigastat (LCQ908) Regimen | At least one Adverse Event (any) | 10 | Participants | |
| Number of Patients With Any Adverse Events, Serious Adverse Events and Death | Pradigastat (LCQ908) Regimen- From Study A2212 | At least one Adverse Event (any) | 5 | Participants | |
| Number of Patients With Any Adverse Events, Serious Adverse Events and Death | Placebo of Pradigastat (LCQ908) Regimen | At least one serious AE | 1 | Participants | |
| Number of Patients With Any Adverse Events, Serious Adverse Events and Death | 20 mg Pradigastat (LCQ908) Regimen | At least one serious AE | 6 | Participants | |
| Number of Patients With Any Adverse Events, Serious Adverse Events and Death | 40 mg Pradigastat (LCQ908) Regimen | At least one serious AE | 2 | Participants | |
| Number of Patients With Any Adverse Events, Serious Adverse Events and Death | Pradigastat (LCQ908) Regimen- From Study A2212 | At least one serious AE | 2 | Participants | |
| Number of Patients With Any Adverse Events, Serious Adverse Events and Death | Placebo of Pradigastat (LCQ908) Regimen | Death | 0 | Participants | |
| Number of Patients With Any Adverse Events, Serious Adverse Events and Death | 20 mg Pradigastat (LCQ908) Regimen | Death | 0 | Participants |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A (52 Weeks) | STARTED | Placebo of Pradigastat (LCQ908) Regimen | 11 | |
| Part A (52 Weeks) | STARTED | 20 mg Pradigastat (LCQ908) Regimen | 12 | |
| Part A (52 Weeks) | STARTED | 40 mg Pradigastat (LCQ908) Regimen | 10 | |
| Part A (52 Weeks) | STARTED | Pradigastat (LCQ908) Regimen- From Study A2212 | 5 | |
| Part A (52 Weeks) | COMPLETED | Placebo of Pradigastat (LCQ908) Regimen | 9 | |
| Part A (52 Weeks) | COMPLETED | 20 mg Pradigastat (LCQ908) Regimen | 9 | |
| Part A (52 Weeks) | COMPLETED | 40 mg Pradigastat (LCQ908) Regimen | 8 | |
| Part A (52 Weeks) | COMPLETED | Pradigastat (LCQ908) Regimen- From Study A2212 | 5 | |
| Part A (52 Weeks) | NOT COMPLETED | Placebo of Pradigastat (LCQ908) Regimen | 2 | |
| Part A (52 Weeks) | NOT COMPLETED | 20 mg Pradigastat (LCQ908) Regimen | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events816
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Part A-placebo of Pradigastat (LCQ908) Regimen | 1 | 11 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Part A-20mg Pradigastat (LCQ908) Regimen | 1 | 12 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Part A-40mg Pradigastat (LCQ908) Regimen | 0 | 10 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Part A: Pradigastat (LCQ908) Regimen- From Study A2212 | 1 | 5 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Part B-placebo of Pradigastat (LCQ908) Regimen | 0 | 5 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Part B-20mg Pradigastat (LCQ908) Regimen | 0 | 6 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Part B- Pradigastat (LCQ908) Regimen- From Study A2212 | 0 | 4 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Part B-40 mg Pradigastat (LCQ908) | 0 | 4 | |
| other | CARDIAC FAILURE | Cardiac disorders | Part A-placebo of Pradigastat (LCQ908) Regimen | 0 | 11 | |
| other | CARDIAC FAILURE | Cardiac disorders | Part A-20mg Pradigastat (LCQ908) Regimen | 1 | 12 |
1 to 10 of 816Source ClinicalTrials.gov
See all 816 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A-placebo of Pradigastat (LCQ908) Regimen | ||
| Total, all-cause mortality | Part A-20mg Pradigastat (LCQ908) Regimen | ||
| Total, all-cause mortality | Part A-40mg Pradigastat (LCQ908) Regimen | ||
| Total, all-cause mortality | Part A: Pradigastat (LCQ908) Regimen- From Study A2212 | ||
| Total, all-cause mortality | Part B-placebo of Pradigastat (LCQ908) Regimen | ||
| Total, all-cause mortality | Part B-20mg Pradigastat (LCQ908) Regimen | ||
| Total, all-cause mortality | Part B- Pradigastat (LCQ908) Regimen- From Study A2212 | ||
| Total, all-cause mortality | Part B-40 mg Pradigastat (LCQ908) | ||
| Total, other adverse events | Part A-placebo of Pradigastat (LCQ908) Regimen | 11 | 11 |
| Total, other adverse events | Part A-20mg Pradigastat (LCQ908) Regimen | 12 | 12 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01589237
GET https://conductscience.org/api/trials/v1/NCT01589237/results?page=2