Trial · NCT00645099
A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia
NCT00645099, Phase 3, Completed, Janssen-Cilag International NV; results first posted 2010-07-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia. Trials, record NCT00645099. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00645099
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia
- NCT number
- NCT00645099
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 462 participants, actual
- Lead sponsor
- Janssen-Cilag International NV
- Conditions
- Schizophrenia
- Interventions
- olanzapine, paliperidone ER
- First posted
- 2008-03-27
- Last updated
- 2014-05-08
- Results first posted
- 2010-07-29
- Limitations and caveats
- Open-label design
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to End Point in the Triglycerides (TG) to High Density Lipoprotein (HDL) Ratio (TG:HDL Ratio) | Baseline to End Point (up to 6 months) | Plasma fasting TG and HDL concentrations were measured to determine the TG:HDL ratio. |
| Secondary | Change From Baseline to End Point in Triglycerides | Baseline to End Point (up to 6 months) | The TG level was assessed under fasted conditions. |
| Secondary | Change From Baseline to End Point in High Density Lipoprotein | Baseline to End Point (up to 6 months) | The HDL level was assessed under fasted conditions. |
| Secondary | Change From Baseline to End Point in Total Cholesterol | Baseline to End Point (up to 6 months) | The total cholesterol level was assessed under fasted conditions. |
| Secondary | Change From Baseline to End Point in Low Density Lipoprotein Cholesterol (Friedwald QT) | Baseline to End Point (up to 6 months) | The level of low density lipoprotein cholesterol was calculated using the Friedwald QT formula. |
| Secondary | Change From Baseline to End Point in Converted Insulin | Baseline to End Point (up to 6 months) | The insulin level was assessed under fasted conditions. |
| Secondary | Change From Baseline to End Point in Fasting Glucose | Baseline to End Point (up to 6 months) | |
| Secondary | Change From Baseline to End Point in Homeostatic Model Assessment of Beta-cell Function (HOMA-%B) | Baseline to End Point (up to 6 months) | HOMA-%B is used to assess beta-cell function. HOMA-%B is a dimensionless measure of beta-cell function (higher values present increased insulin secretion for a given glucose level). HOMA-%B is normalized so that lean, healthy individuals will have values of HOMA-%B close to 100%. |
| Secondary | Change From Baseline to End Point in Homeastatic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline to End Point (up to 6 months) | HOMA-IR is used to assess insulin resistance (IR). HOMA-IR is a dimensionless measure of insulin resistance (higher values present more insulin resistance. HOMA-IR are normalized so that lean, healthy individuals will have values of HOMA-IR close to 1. |
| Secondary | Number of Patients Meeting the Criteria for Type 2 Diabetes Mellitus During Follow-up | 6 months | Fasting plasma glucose ≥126 mg/dL or 2-hour post-load plasma glucose ≥200 mg/dL during an oral glucose tolerance test (OGTT) or initiated use of glucose-lowering agents during the course of the study. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to End Point in the Triglycerides (TG) to High Density Lipoprotein (HDL) Ratio (TG:HDL Ratio) | Baseline to End Point (up to 6 months) | The primary end point analysis set consisted of 413 patients, i.e., all patients who received study medication at least once and had baseline and post-baseline TG and HDL data. Data of patients with missing TG or HDL values or who started or changed lipid-lowering medication during the trial were excluded from analysis. | Ratio | MEAN |
| SECONDARY | Change From Baseline to End Point in Triglycerides | Baseline to End Point (up to 6 months) | The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion. | mmol/L | MEAN |
| SECONDARY | Change From Baseline to End Point in High Density Lipoprotein | Baseline to End Point (up to 6 months) | The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion. | mmol/L | MEAN |
| SECONDARY | Change From Baseline to End Point in Total Cholesterol | Baseline to End Point (up to 6 months) | Safety data were analyzed using the Intent-to-Treat (ITT) analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data. | mmol/L | MEAN |
| SECONDARY | Change From Baseline to End Point in Low Density Lipoprotein Cholesterol (Friedwald QT) | Baseline to End Point (up to 6 months) | Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data. | mmol/L | MEAN |
| SECONDARY | Change From Baseline to End Point in Converted Insulin | Baseline to End Point (up to 6 months) | Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data. | pmol/L | MEAN |
| SECONDARY | Change From Baseline to End Point in Fasting Glucose | Baseline to End Point (up to 6 months) | Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data. | mmol/L | MEAN |
| SECONDARY | Change From Baseline to End Point in Homeostatic Model Assessment of Beta-cell Function (HOMA-%B) | Baseline to End Point (up to 6 months) | The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post baseline data for the particular secondary efficacy parameter under discussion. | dimensionless | MEAN |
| SECONDARY | Change From Baseline to End Point in Homeastatic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline to End Point (up to 6 months) | The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion. | dimensionless | MEAN |
| SECONDARY | Number of Patients Meeting the Criteria for Type 2 Diabetes Mellitus During Follow-up | 6 months | The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement.Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion. | Participants | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to End Point in the Triglycerides (TG) to High Density Lipoprotein (HDL) Ratio (TG:HDL Ratio) | Paliperidone ER | -0.08 | Standard Deviation 1.10 | Ratio | |
| Change From Baseline to End Point in the Triglycerides (TG) to High Density Lipoprotein (HDL) Ratio (TG:HDL Ratio) | Olanzapine | 0.42 | Standard Deviation 1.19 | Ratio | |
| Change From Baseline to End Point in Triglycerides | Paliperidone ER | -0.01 | Standard Deviation 0.77 | mmol/L | |
| Change From Baseline to End Point in Triglycerides | Olanzapine | 0.36 | Standard Deviation 0.96 | mmol/L | |
| Change From Baseline to End Point in High Density Lipoprotein | Paliperidone ER | 0.01 | Standard Deviation 0.25 | mmol/L | |
| Change From Baseline to End Point in High Density Lipoprotein | Olanzapine | -0.04 | Standard Deviation 0.24 | mmol/L | |
| Change From Baseline to End Point in Total Cholesterol | Paliperidone ER | 0.0263 | Standard Deviation 0.7841 | mmol/L | |
| Change From Baseline to End Point in Total Cholesterol | Olanzapine | 0.2886 | Standard Deviation 0.8493 | mmol/L | |
| Change From Baseline to End Point in Low Density Lipoprotein Cholesterol (Friedwald QT) | Paliperidone ER | -0.0029 | Standard Deviation 0.6726 | mmol/L | |
| Change From Baseline to End Point in Low Density Lipoprotein Cholesterol (Friedwald QT) | Olanzapine | 0.1892 | Standard Deviation 0.7361 | mmol/L |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paliperidone Extended Release (ER) | 239 | |
| Overall Study | STARTED | Olanzapine | 220 | |
| Overall Study | COMPLETED | Paliperidone Extended Release (ER) | 168 | |
| Overall Study | COMPLETED | Olanzapine | 178 | |
| Overall Study | NOT COMPLETED | Paliperidone Extended Release (ER) | 71 | |
| Overall Study | NOT COMPLETED | Olanzapine | 42 |
Source ClinicalTrials.gov
Adverse events106
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 | Weight increased | Investigations | Paliperidone ER | 23 | 239 | |
| other | Weight increased | Investigations | Olanzapine | 40 | 220 | |
| other | Blood creatine phosphokinase increased | Investigations | Paliperidone ER | 7 | 239 | |
| other | Blood creatine phosphokinase increased | Investigations | Olanzapine | 5 | 220 | |
| other | Alanine aminotransferase increased | Investigations | Paliperidone ER | 1 | 239 | |
| other | Alanine aminotransferase increased | Investigations | Olanzapine | 3 | 220 | |
| other | Blood glucose increased | Investigations | Paliperidone ER | 1 | 239 | |
| other | Blood glucose increased | Investigations | Olanzapine | 3 | 220 | |
| other | Gamma-glutamyltransferase increased | Investigations | Paliperidone ER | 1 | 239 | |
| other | Gamma-glutamyltransferase increased | Investigations | Olanzapine | 3 | 220 |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paliperidone ER | ||
| Total, all-cause mortality | Olanzapine | ||
| Total, other adverse events | Paliperidone ER | 98 | 239 |
| Total, other adverse events | Olanzapine | 93 | 220 |
| Total, serious adverse events | Paliperidone ER | 21 | 239 |
| Total, serious adverse events | Olanzapine | 12 | 220 |
Source ClinicalTrials.gov
Papers0
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Paliperidone ER vs Olanzapine: Number of Patients With Onset of Impaired Glucose Tolerance | Trial comparisons |
| Paliperidone ER vs Olanzapine: Number of Patients First Meeting the NCEP/ATP III Criteria for Metabolic Syndrome During Follow-up | Trial comparisons |
| Paliperidone ER vs Olanzapine: Number of Patients Meeting the Criteria for Type 2 Diabetes Mellitus During Follow-up | Trial comparisons |
| Paliperidone ER vs Olanzapine: Number of Patients With Impaired Fasting Glucose | Trial comparisons |
| Paliperidone ER vs Olanzapine: serious adverse events | Trial comparisons |
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/NCT00645099
GET https://conductscience.org/api/trials/v1/NCT00645099/results?page=2