Trial · NCT00748566
One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome
NCT00748566, Phase 4, Terminated, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2013-06-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome. Trials, record NCT00748566. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00748566
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome
- NCT number
- NCT00748566
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 172 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Schizophrenia and Disorders With Psychotic Features
- Interventions
- Ziprasidone HCL (oral)
- First posted
- 2008-09-08
- Last updated
- 2021-03-03
- Results first posted
- 2013-06-19
- Limitations and caveats
- The study was prematurely terminated by sponsor due to changes in organizational strategy and resources, not due to safety concerns.
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS) | Endpoint (premature discontinuation or Week 52) | MS risks factors: elevated (el) waist, men:\>=102 centimeters(cm), women:\>=88 cm (Asian origin:\>=90 cm in men, \>=80 cm in women); el triglycerides: \>=1.7 millimoles per liter (mmol/L) (\>=150 milligram per deciliter \[mg/dL\]); reduced high-density lipoprotein cholesterol (HDL-C), men:\<1.03 mmol/L (\<40 mg/dL), women:\<1.3 mmol/L (\<50 mg/dL); el fasting glucose: \>=5.6 mmol/L (\>=100 mg/dL); el systolic/diastolic blood pressure (SBP/DBP): SBP\>=130 millimeters of mercury (mmHg) and/or DBP\>=85 mmHg. Responder=at least 1 less risk factor at endpoint (premature discontinuation or Week 52) than baseline. |
| Secondary | Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | MS risks factors: elevated waist circumference: greater than or equal to (\>=)102 cm in men, \>=88 cm in women (Asian origin: \>=90 cm \[men\], \>=80 cm \[women\]); elevated triglycerides: \>=1.7 mmol/L (\>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): less than (\<)1.03 mmol/L (\<40 mg/dL) in men, \<1.3 mmol/L (\<50 mg/dL) in women; elevated fasting glucose: \>=5.6 mmol/L (\>=100 mg/dL); elevated SBP/DBP: SBP \>=130 mmHg and/or DBP \>=85 mmHg. |
| Secondary | Percentage of Participants With Metabolic Syndrome (MS) | Baseline, Week 4, 12, 28, 52 | According to the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATPIII), metabolic syndrome is defined as a condition that includes 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose. |
| Secondary | Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 | Week 4, 12, 28, 52 | MS risks factors: elevated waist circumference: \>=102 cm in men, \>=88 cm in women (Asian origin: \>=90 cm \[men\], \>=80 cm \[women\]); elevated triglycerides: \>=1.7 mmol/L (\>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): \<1.03 mmol/L (\<40 mg/dL) in men, \<1.3 mmol/L (\<50 mg/dL) in women; elevated fasting glucose: \>=5.6 mmol/L (\>=100 mg/dL); elevated SBP/DBP: SBP \>=130 mmHg and/or DBP \>=85 mmHg. |
| Secondary | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Baseline, Week 4, 12, 28, 52 | MS risks factors: elevated waist circumference: \>=102 cm in men, \>=88 cm in women (Asian origin: \>=90 cm \[men\], \>=80 cm \[women\]); elevated triglycerides: \>=1.7 mmol/L (\>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): \<1.03 mmol/L (\<40 mg/dL) in men, \<1.3 mmol/L (\<50 mg/dL) in women; elevated fasting glucose: \>=5.6 mmol/L (\>=100 mg/dL); elevated SBP/DBP: SBP \>=130 mmHg and/or DBP \>=85 mmHg. |
| Secondary | Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | Waist circumference data is reported separately for male and female participants. |
| Secondary | Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | BP measurement is recorded as systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). |
| Secondary | Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | Triglyceride data is reported for whole study population whereas HDL-C data is reported separately for male and female participants. |
| Secondary | Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | |
| Secondary | Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | Framingham scoring system risk factors: age (risk points range: -9 to 16), cholesterol (risk points range: 0 to 13), HDL cholesterol (risk points range: -1 to 2), smoking (risk points range: 0 to 9), and systolic blood pressure (risk points range: 0 to 6); total risk points range \<0 to \>=25, higher score indicates higher CHD risk. The risk points are transformed to 10-year risk percentage for CHD which ranges from \<1% to \>=30%, where higher percent indicates greater risk for CHD. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS) | Endpoint (premature discontinuation or Week 52) | Per protocol (PP) population included all enrolled participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline MS measure, and remained in the study for at least 16 weeks. Missing values were imputed using last observation carried forward (LOCF). | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points. | risk factors | MEAN |
| SECONDARY | Percentage of Participants With Metabolic Syndrome (MS) | Baseline, Week 4, 12, 28, 52 | PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 | Week 4, 12, 28, 52 | PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points. | participants | NUMBER |
| SECONDARY | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Baseline, Week 4, 12, 28, 52 | PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points. | cm | MEAN |
| SECONDARY | Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points. | percent of 10-year CHD risk | MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group165
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS) | Ziprasidone | 58.77 | 95% Confidence Interval 47.0 to 71.0 | percentage of participants | |
| Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52 | Ziprasidone | Baseline (n=114) | 3.4 | Standard Deviation 1.0 | risk factors |
| Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52 | Ziprasidone | Change at Week 4 (n=113) | -0.3 | Standard Deviation 1.0 | risk factors |
| Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52 | Ziprasidone | Change at Week 12 (n=112) | -0.4 | Standard Deviation 1.1 | risk factors |
| Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52 | Ziprasidone | Change at Week 28 (n=98) | -0.7 | Standard Deviation 1.3 | risk factors |
| Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52 | Ziprasidone | Change at Week 52 (n=114) | -0.8 | Standard Deviation 1.2 | risk factors |
| Percentage of Participants With Metabolic Syndrome (MS) | Ziprasidone | Baseline (n=114) | 79.82 | 95% Confidence Interval 71.6 to 88.1 | percentage of participants |
| Percentage of Participants With Metabolic Syndrome (MS) | Ziprasidone | Week 4 (n=113) | 70.80 | 95% Confidence Interval 60.8 to 80.8 | percentage of participants |
| Percentage of Participants With Metabolic Syndrome (MS) | Ziprasidone | Week 12 (n=112) | 72.32 | 95% Confidence Interval 62.6 to 82.1 | percentage of participants |
| Percentage of Participants With Metabolic Syndrome (MS) | Ziprasidone | Week 28 (n=98) | 58.16 | 95% Confidence Interval 45.4 to 71.0 | percentage of participants |
1 to 10 of 165Source ClinicalTrials.gov
See all 165 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ziprasidone | 172 | |
| Overall Study | COMPLETED | Ziprasidone | 60 | |
| Overall Study | NOT COMPLETED | Ziprasidone | 112 |
Source ClinicalTrials.gov
Adverse events29
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 | Diarrhoea | Gastrointestinal disorders | Ziprasidone | 11 | 172 | |
| other | Nausea | Gastrointestinal disorders | Ziprasidone | 28 | 172 | |
| other | Vomiting | Gastrointestinal disorders | Ziprasidone | 11 | 172 | |
| other | Fatigue | General disorders | Ziprasidone | 21 | 172 | |
| other | Nasopharyngitis | Infections and infestations | Ziprasidone | 13 | 172 | |
| other | Akathisia | Nervous system disorders | Ziprasidone | 11 | 172 | |
| other | Dizziness | Nervous system disorders | Ziprasidone | 15 | 172 | |
| other | Headache | Nervous system disorders | Ziprasidone | 22 | 172 | |
| other | Somnolence | Nervous system disorders | Ziprasidone | 17 | 172 | |
| other | Anxiety | Psychiatric disorders | Ziprasidone | 33 | 172 |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ziprasidone | ||
| Total, other adverse events | Ziprasidone | 122 | 172 |
| Total, serious adverse events | Ziprasidone | 20 | 172 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24568177 | DERIVED |
Source PubMed
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/NCT00748566
GET https://conductscience.org/api/trials/v1/NCT00748566/registered?page=2