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| ID | Type | Description | Link |
|---|---|---|---|
| F1D-MC-S014 | Other Identifier | Eli Lilly and Company |
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This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olanzapine | Experimental |
| |
| Risperidone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olanzapine | Drug | 5-20 mg, oral, capsules, daily, 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate | Normalized insulin sensitivity index (Mffm/I) was defined as the ratio of whole body glucose disposal rate normalized to fat-free mass (Mffm) divided by the plasma insulin concentration (I) during steady-state conditions of the clamp procedure. Units:[(mg glucose)*min*mL] / [(kg fat free body mass)*(micro IU insulin)] | baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in weight | 12 weeks |
| Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Diego | California | 92161 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20840778 | Derived | Case M, Treuer T, Karagianis J, Hoffmann VP. The potential role of appetite in predicting weight changes during treatment with olanzapine. BMC Psychiatry. 2010 Sep 14;10:72. doi: 10.1186/1471-244X-10-72. |
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Study Period I was a Screening Period. Study Period II was a Inpatient Washout/Diet Stabilization Period. Study Period III (randomization) was the Double-Blind Therapy Period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olanzapine | Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks. |
| FG001 | Risperidone | Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Olanzapine | Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks. |
| BG001 | Risperidone | Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate | Normalized insulin sensitivity index (Mffm/I) was defined as the ratio of whole body glucose disposal rate normalized to fat-free mass (Mffm) divided by the plasma insulin concentration (I) during steady-state conditions of the clamp procedure. Units:[(mg glucose)*min*mL] / [(kg fat free body mass)*(micro IU insulin)] | N=number of patients with a baseline and post-baseline result within each treatment group for Mffm/I and weight. | Posted | Mean | Standard Deviation | Mffm/I | baseline and 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olanzapine | Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| risperidone | Drug | 2-6 mg, oral, capsules, twice daily (BID), 12 weeks. |
|
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in BMI |
| 12 weeks |
| Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Ratio of Visceral Fat Area to the Subcutaneous Fat Area. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in ratio of visceral far area to subcutaneous fat area | 12 weeks |
| Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores. | Normalized insulin senstivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Brief Psychiatric Rating Scale scores | 12 weeks |
| Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Clinical Global Impression-Severity of Illness scale scores | 12 weeks |
| Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Abnormal Involuntary Movement Scale scores | 12 weeks |
| Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Barnes Akathisia scores | 12 weeks |
| Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in the Simpson Angus Scale scores | 12 weeks |
| Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in waist circumference | 12 weeks |
| Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in visceral fat area | 12 weeks |
| Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in subcutaneous fat area | 12 weeks |
| Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Eating Behavior Assessment Scale scores | 12 weeks |
| Change From Baseline to 12 Week Endpoint in Body Mass Index | Within-and Between-Treatment Group changes in Body Mass Index from baseline to last observation carried forward. | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Weight | Weight change from baseline to last visit (last observation carried forward) | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Waist Circumference | Waist circumference change from baseline to last observation carried forward. | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Visceral Fat Area | Visceral fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area | Subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area | Ratio of the visceral fat area to the subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores | Brief Psychiatric Rating Scale (BPRS) is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Item scores range from 0 (not present) to 6 (extremely severe). Total Scores range from 0 to 108; Positive Subscale Scores range from 0 to 24. Negative Subscale Scores range from 0 to 18. Anxiety-Depression Subscale Scores range from 0 to 24. | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores | Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores | A 12-item instrument assesses observed abnormal movements in different parts of body. Seven items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in 3 main anatomic areas (orofacial area, extremities, and trunk). Total scores range from 0 to 28. Five collected elements are not used in this total. | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores | The BARS is a 4-item instrument that evaluates akathisia associated with use of antipsychotic medications. Item 4 is the Global clinical assessment and is rated 0 to 5 (0 = absent, 5 = severe). The other 3 items (related to objective and subjective assessments) are not used for these analyses. | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores | Measures neuroleptic-induced parkinsonism. Total score of Simpson Angus Scale consists of the sum of 10 items rated on a 5-point severity scale where 0=normal and 4=extreme. The total score ranges from 0 to 40. | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Eating Behavior Assessment Scale is a 9-item self-rated tool used to evaluate appetite and eating behaviors. Item scores range from 0 (never) to 4 (always). | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol | Fasting lipid parameters including total cholesterol, change from baseline to last observation carried forward. | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL) | Fasting lipid parameters including Direct LDL, change from baseline to last observation carried forward. | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL) | Fasting lipid parameters including HDL change from baseline to last observation carried forward. | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides | Changes in fasting lipid parameters including triglycerides last observation carried forward (LOCF) mean change from baseline | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | Changes in lipid parameters and subclass lipoproteins last observation carried forward (LOCF) mean change from baseline. HDL=High Density Lipoprotein, IDL=Intermdiate Density Lipoprotein, LDL=Low Density Lipoprotein, VLDL=Very Low Density Lipoprotein. | baseline and 12 weeks. |
| United States |
| Protocol Violation |
|
| Adverse Event |
|
| Lack of Efficacy |
|
| Reason Not Specified |
|
| Sponsor Decision |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosis | Number | participants |
|
| Race/Ethnicity | Number | participants |
|
| Brief Psychiatric Rating Scale Anxiety Depression Score-Baseline | Brief Psychiatric Rating Scale (BPRS) Anxiety-Depression Score assesses the degree of severity of a subject's anxiety-depression symptoms. BPRS Anxiety-Depression Score is the sum of Item Scores 1, 2, 5 and 9. Item scores range from 0 (not present) to 6 (extremely severe). Total Scores for Anxiety-Depression range from 0 to 24. | Mean | Standard Deviation | units on a scale |
|
| Brief Psychiatric Rating Scale Negative Symptom Score-Baseline | Brief Psychiatric Rating Scale (BPRS) Negative Score assesses the degree of severity of a subject's negative symptoms. BPRS Negative Score is the sum of Item Scores 3, 13, and 16. Item scores range from 0 (not present) to 6 (extremely severe). Total Scores for Negative Score range from 0 to 18. | Mean | Standard Deviation | units on a scale |
|
| Brief Psychiatric Rating Scale Positive Symptom Score-Baseline | Brief Psychiatric Rating Scale (BPRS) Positive Score assesses the degree of severity of a subject's positive symptoms. BPRS Positive Score is the sum of Item Scores 4, 11, 12, and 15. Item scores range from 0 (not present) to 6 (extremely severe). Total Scores for Positive Score range from 0 to 24. | Mean | Standard Deviation | units on a scale |
|
| Brief Psychiatric Rating Scale Total Score-Baseline | Brief Psychiatric Rating Scale (BPRS) Total Score is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Item scores range from 0 (not present) to 6 (extremely severe). Total Scores range from 0 to 108. | Mean | Standard Deviation | units on a scale |
|
| Clinical Global Impression Severity Score- Baseline | Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | Mean | Standard Deviation | units on a scale |
|
| Extrapyramidal Scores/Abnormal Involuntary Movement-Baseline | A 12-item instrument assesses observed abnormal movements in different parts of body. Seven items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in 3 main anatomic areas (orofacial area, extremities, and trunk). Total scores range from 0 to 28. Five collected elements are not used in this total. | Mean | Standard Deviation | units on a scale |
|
| Extrapyramidal Scores/Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment-Baseline | The BARS is a 4-item instrument that evaluates akathisia associated with use of antipsychotic medications. Item 4 is the Global clinical assessment and is rated 0 to 5 (0 = absent, 5 = severe). | Mean | Standard Deviation | units on a scale |
|
| Extrapyramidal Scores/Simpson-Angus-Baseline | Measures neuroleptic-induced parkinsonism. Total score of Simpson Angus Scale consists of the sum of 10 itemsrated on a 5-point severity scale where 0=normal and 4=extreme. The total score ranges from 0 to 40. | Mean | Standard Deviation | units on a scale |
|
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks. |
|
|
|
| Secondary | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in weight | Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations. | Posted | Number | correlation | 12 weeks |
|
|
|
|
| Secondary | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI) | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in BMI | Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations. | Posted | Number | correlation | 12 weeks |
|
|
|
|
| Secondary | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Ratio of Visceral Fat Area to the Subcutaneous Fat Area. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in ratio of visceral far area to subcutaneous fat area | Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations. | Posted | Number | correlation | 12 weeks |
|
|
|
|
| Secondary | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores. | Normalized insulin senstivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Brief Psychiatric Rating Scale scores | Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations. | Posted | Number | correlation | 12 weeks |
|
|
|
|
| Secondary | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Clinical Global Impression-Severity of Illness scale scores | Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations. | Posted | Number | correlation | 12 weeks |
|
|
|
|
| Secondary | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Abnormal Involuntary Movement Scale scores | Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations. | Posted | Number | correlation | 12 weeks |
|
|
|
|
| Secondary | Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Barnes Akathisia scores | Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations. | Posted | Number | correlation | 12 weeks |
|
|
|
|
| Secondary | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in the Simpson Angus Scale scores | Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations. | Posted | Number | correlation | 12 weeks |
|
|
|
|
| Secondary | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in waist circumference | Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations | Posted | Number | correlation | 12 weeks |
|
|
|
|
| Secondary | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in visceral fat area | Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations | Posted | Number | correlation | 12 weeks |
|
|
|
|
| Secondary | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in subcutaneous fat area | Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations. | Posted | Number | correlation | 12 weeks |
|
|
|
|
| Secondary | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Eating Behavior Assessment Scale scores | Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations. | Posted | Number | correlation | 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Body Mass Index | Within-and Between-Treatment Group changes in Body Mass Index from baseline to last observation carried forward. | Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations | Posted | Mean | Standard Deviation | kilograms per square meter (kg/m2) | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Weight | Weight change from baseline to last visit (last observation carried forward) | Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations. | Posted | Mean | Standard Deviation | kilograms | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Waist Circumference | Waist circumference change from baseline to last observation carried forward. | Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations. | Posted | Mean | Standard Deviation | centimeters | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Visceral Fat Area | Visceral fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period | Abdominal CT scan of changes from baseline to last observation of randomized patients who completed baseline and endpoint clamps with both diet stabilizations | Posted | Mean | Standard Deviation | square centimeters (cm2) | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area | Subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period | Abdominal CT scan change from baseline to last observation for randomized patients who completed baseline and endpoint clamps with both diet stabilizations | Posted | Mean | Standard Deviation | square centimeters (cm2) | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area | Ratio of the visceral fat area to the subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period | Abdominal CT scan change from baseline to last observation of randomized patients who completed the baseline and endpoint clamps with both diet stabilizations | Posted | Mean | Standard Deviation | ratio in square centimeters (cm2) | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores | Brief Psychiatric Rating Scale (BPRS) is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Item scores range from 0 (not present) to 6 (extremely severe). Total Scores range from 0 to 108; Positive Subscale Scores range from 0 to 24. Negative Subscale Scores range from 0 to 18. Anxiety-Depression Subscale Scores range from 0 to 24. | BPRS Total and Subscale Scores-Change from Baseline to Last Observation Carried Forward, all randomized patients, double-blind treatment period | Posted | Mean | Standard Deviation | units on a scale | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores | Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. | Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period | Posted | Mean | Standard Deviation | units on a scale | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores | A 12-item instrument assesses observed abnormal movements in different parts of body. Seven items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in 3 main anatomic areas (orofacial area, extremities, and trunk). Total scores range from 0 to 28. Five collected elements are not used in this total. | Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period | Posted | Mean | Standard Deviation | units on a scale | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores | The BARS is a 4-item instrument that evaluates akathisia associated with use of antipsychotic medications. Item 4 is the Global clinical assessment and is rated 0 to 5 (0 = absent, 5 = severe). The other 3 items (related to objective and subjective assessments) are not used for these analyses. | Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period | Posted | Mean | Standard Deviation | units on a scale | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores | Measures neuroleptic-induced parkinsonism. Total score of Simpson Angus Scale consists of the sum of 10 items rated on a 5-point severity scale where 0=normal and 4=extreme. The total score ranges from 0 to 40. | Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period | Posted | Mean | Standard Deviation | units on a scale | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Eating Behavior Assessment Scale is a 9-item self-rated tool used to evaluate appetite and eating behaviors. Item scores range from 0 (never) to 4 (always). | Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period | Posted | Mean | Standard Deviation | units on a scale | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol | Fasting lipid parameters including total cholesterol, change from baseline to last observation carried forward. | Change from baseline to last observation, all randomized patients, double-blind treatment period | Posted | Mean | Standard Deviation | millimoles per Liter (mmol/L) | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL) | Fasting lipid parameters including Direct LDL, change from baseline to last observation carried forward. | Change from baseline to last observation, all randomized patients, double-blind treatment period | Posted | Mean | Standard Deviation | millimoles per Liter (mmol/L) | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL) | Fasting lipid parameters including HDL change from baseline to last observation carried forward. | Change from baseline to last observation, all randomized patients, double-blind treatment period | Posted | Mean | Standard Deviation | millimoles per Liter (mmol/L) | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides | Changes in fasting lipid parameters including triglycerides last observation carried forward (LOCF) mean change from baseline | Change from baseline to last observation, all randomized patients, double-blind treatment period | Posted | Mean | Standard Deviation | millimoles per Liter (mmol/L) | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | Changes in lipid parameters and subclass lipoproteins last observation carried forward (LOCF) mean change from baseline. HDL=High Density Lipoprotein, IDL=Intermdiate Density Lipoprotein, LDL=Low Density Lipoprotein, VLDL=Very Low Density Lipoprotein. | Mean change from baseline, all randomized patients, double-blind treatment period | Posted | Mean | Standard Deviation | nanomoles per Liter (nmol/L) | baseline and 12 weeks. |
|
|
|
|
| 2 |
| 68 |
| 42 |
| 68 |
| EG001 | Risperidone | Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks. | 5 | 62 | 43 | 62 |
| Psychotic disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Schizoaffective disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Discomfort | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
Not provided
| D006571 | Heterocyclic Compounds |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| 95 |
| No |
| Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Item 3: Craved Sweets or Other Carbohydrates? |
|
| Item 4: Craved Fatty Foods? |
|
| Item 5: Felt Full or Satisfied After Meal? |
|
| Item 6:Excessive Amount of Food to Feel Satisfied? |
|
| Item 7: Thinking About Food? |
|
| Item 8: Overeating? |
|
| Item 9: Feel Eating is Out of Control? |
|
| 0.033 |
| 95 |
| No |
| Superiority or Other |
| Change in Eating Behavior Item 2 | Pearson's correlation coefficient | 0.392 | 95 | No | Superiority or Other |
| Change in Eating Behavior Item 2 | Pearson's correlation coefficient | 0.129 | 95 | No | Superiority or Other |
| Change in Eating Bahavior Item 3 | Pearson's correlation coefficient | 0.956 | 95 | No | Superiority or Other |
| Change in Eating Behavior Item 3 | Pearson's correlation coefficient | 0.846 | 95 | No | Superiority or Other |
| Change in Eating Behavior Item 4 | Pearson's correlation coefficient | 0.675 | 95 | No | Superiority or Other |
| Change in Eating Behavior Item 4 | Pearson's correlation coefficient | 0.306 | 95 | No | Superiority or Other |
| Change in Eating Behavior Item 5 | Pearson's correlation coefficient | 0.468 | 95 | No | Superiority or Other |
| Change in Eating Behavior Item 5 | Pearson's correlation coefficient | 0.739 | 95 | No | Superiority or Other |
| Change in Eating Behavior Item 6 | Pearson's correlation coefficient | 0.404 | 95 | No | Superiority or Other |
| Change in Eating Behavior Item 6 | Pearson's correlation coefficient | 0.711 | 95 | No | Superiority or Other |
| Change in Eating Behavior Item 7 | Pearson's correlation coefficient | 0.281 | 95 | No | Superiority or Other |
| Change in Eating Behavior Item 7 | Pearson's correlation coefficient | 0.805 | 95 | No | Superiority or Other |
| Change in Eating Behavior Item 8 | Pearson's correlation coefficient | 0.844 | 95 | No | Superiority or Other |
| Change in Eating Bahavior Item 8 | Pearson's correlation coefficient | 0.359 | 95 | No | Superiority or Other |
| Change in Eating Behavior Item 9 | Pearson's correlation coefficient | 0.642 | 95 | No | Superiority or Other |
| Change in Eating Behavior Item 9 | Pearson's correlation coefficient | 0.043 | 95 | No | Superiority or Other |
| 0.019 |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator | 0.065 | 95 | No | Superiority or Other |
| 0.013 |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change = Baseline Treatment Pooled Investigator | 0.076 | 95 | No | Superiority or Other |
| 0.266 |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change = Baseline Treatment Pooled Investigator | 0.239 | 95 | No | Superiority or Other |
| 0.105 |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change= Baseline Treatment Pooled Investigator | 0.609 | 95 | No | Superiority or Other |
| 0.011 |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | Overall group p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.076 | 95 | No | Superiority or Other |
| 0.712 |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change= Baseline Treatment Pooled Investigator | 0.689 | 95 | No | Superiority or Other |
| Positive Subscale Score Baseline |
|
| Positive Subscale Score Change to Last Observation |
|
| Negative Subscale Score Baseline |
|
| Negative Subscale Score Change to Last Observation |
|
| Anxiety-Depression Baseline |
|
| Anxiety-Depression Change to Last Observation |
|
Within group p-values are from t-tests on LSMean changes |
| 0.159 |
| 95 |
| No |
| Superiority or Other |
| Total Score | ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator | 0.951 | 95 | No | Superiority or Other |
| Positive Subscale | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.012 | 95 | No | Superiority or Other |
| Positive subscale | t-test, 2 sided | With group p-values are from t-tests on LSMean | 0.002 | 95 | No | Superiority or Other |
| Positive subscale | ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator | 0.467 | 95 | No | Superiority or Other |
| Negative subscale | t-test, 2 sided | With group p-values are from t-tests on LSMean change | 0.365 | 95 | No | Superiority or Other |
| Negative subscale | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.846 | 95 | No | Superiority or Other |
| Negative subscale | ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.559 | 95 | No | Superiority or Other |
| Anxiety-Depression subscale | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.150 | 95 | No | Superiority or Other |
| Anxiety-Depression subscale | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.612 | 95 | No | Superiority or Other |
| Anxiety-Depression subscale | ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.475 | 95 | No | Superiority or Other |
| 0.010 |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | Overall p-values are from Type 3 sums of square ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.760 | 95 | No | Superiority or Other |
| 0.763 |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.832 | 95 | No | Superiority or Other |
| 0.853 |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.591 | 95 | No | Superiority or Other |
| 0.922 |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | Overall group p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.479 | 95 | No | Superiority or Other |
| Item 2 Baseline (How Strong Appetite?) |
|
| Item 2 Change to Last Observation |
|
| Item 3 Baseline (Craved Sweets or Other Carbos?) |
|
| Item 3 Change to Last Observation |
|
| Item 4 Baseline (Craved Fatty Foods?) |
|
| Item 4 Change to Last Observation |
|
| Item 5 Baseline (Felt Full After Meal?) |
|
| Item 5 Change to Last Observation |
|
| Item 6 Baseline(Excessive Food to Feel Satisfied?) |
|
| Item 6 Change to Last Observation |
|
| Item 7 Baseline (Thinking About Food?) |
|
| Item 7 Change to Last Observation |
|
| Item 8 Baseline (Overeating?) |
|
| Item 8 Change to Last Observation |
|
| Item 9 Baseline (Feel Eating is Out of Control?) |
|
| Item 9 Change to Last Observation |
|
Within group p-values are from t-tests on LSMean change |
| 0.001 |
| 95 |
| No |
| Superiority or Other |
| Item 1 | ANCOVA | Overall p-values are from Type 3 sums of squares, ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.549 | 95 | No | Superiority or Other |
| Item 2 | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.011 | 95 | No | Superiority or Other |
| Item 2 | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.009 | 95 | No | Superiority or Other |
| Item 2 | ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.793 | 95 | No | Superiority or Other |
| Item 3 | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.045 | 95 | No | Superiority or Other |
| Item 3 | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.027 | 95 | No | Superiority or Other |
| Item 3 | ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.699 | 95 | No | Superiority or Other |
| Item 4 | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.002 | 95 | No | Superiority or Other |
| ITem 4 | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.019 | 95 | No | Superiority or Other |
| Item 4 | ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.733 | 95 | No | Superiority or Other |
| Item 5 | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.034 | 95 | No | Superiority or Other |
| Item 5 | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.235 | 95 | No | Superiority or Other |
| Item 5 | ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.532 | 95 | No | Superiority or Other |
| Item 6 | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.242 | 95 | No | Superiority or Other |
| Item 6 | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.186 | 95 | No | Superiority or Other |
| Item 6 | ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.799 | 95 | No | Superiority or Other |
| Item 7 | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.097 | 95 | No | Superiority or Other |
| Item 7 | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.214 | 95 | No | Superiority or Other |
| Item 7 | ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.827 | 95 | No | Superiority or Other |
| Item 8 | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.151 | 95 | No | Superiority or Other |
| Item 8 | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.071 | 95 | No | Superiority or Other |
| Item 8 | ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.629 | 95 | No | Superiority or Other |
| Item 9 | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.036 | 95 | No | Superiority or Other |
| Item 9 | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.112 | 95 | No | Superiority or Other |
| Item 9 | ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.806 | 95 | No | Superiority or Other |
| 0.829 |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.352 | 95 | No | Superiority or Other |
| 0.760 |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.997 | 95 | No | Superiority or Other |
| 0.237 |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.996 | 95 | No | Superiority or Other |
| 0.545 |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.024 | 95 | No | Superiority or Other |
| IDL, baseline |
|
| IDL, change to last observation |
|
| Medium small LDL, baseline |
|
| Medium small LDL, change to last observation |
|
| Small LDL, baseline |
|
| Small LDL, change to last observation |
|
| Very small LDL, baseline |
|
| Very small LDL, change to last observation |
|
| VLDL mean particle size, baseline |
|
| VLDL mean particle size, change to last observ. |
|
Within group p-values are from t-tests on LSMean change |
| 0.959 |
| 95 |
| No |
| Superiority or Other |
| HDL particles, total | ANCOVA | 0.038 | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline TReatment Pooled Investigator | 95 | No | Superiority or Other |
| IDL | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.013 | 95 | No | Superiority or Other |
| IDL | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.928 | 95 | No | Superiority or Other |
| IDL | ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.049 | 95 | No | Superiority or Other |
| Medium small LDL | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.009 | 95 | No | Superiority or Other |
| Medium small LDL | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.662 | 95 | No | Superiority or Other |
| Medium small LDL | ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.12 | 95 | No | Superiority or Other |
| Small LDL | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.099 | 95 | No | Superiority or Other |
| Small LDL | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.304 | 95 | No | Superiority or Other |
| Small LDL | ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.024 | 95 | No | Superiority or Other |
| Very small LDL | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.176 | 95 | No | Superiority or Other |
| Very small LDL | t-test, 2 sided | Withn group p-values are from t-tests on LSMean change | 0.246 | 95 | No | Superiority or Other |
| Very small LDL | ANCOVA | 0.033 | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 95 | No | Superiority or Other |
| VLDL mean particle size | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | <0.001 | 95 | No | Superiority or Other |
| VLDL mean particle size | t-test, 2 sided | Within group p-values are from t-tests on LSMean change | 0.047 | 95 | No | Superiority or Other |
| VLDL mean particle size | ANCOVA | Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator | 0.221 | 95 | No | Superiority or Other |