Trial · NCT00748566
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| 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. |
| Secondary | Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | |
| Secondary | Change From Baseline in Weight at Week 4,12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | |
| Secondary | Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | Body mass index calculated as weight in kilograms (kg) divided by height in (meters) squared (m)\^2 . |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. |
| Secondary | Change From Baseline in Insulin Level at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | |
| Secondary | Change From Baseline in the Physical Activity Index Score at Week 28 and 52 | Baseline, Week 28, 52 | Physical activity (exercise) score derived for each participant based on the frequency and intensity of physical activities: regular walking, recreational activity, cycling, and sporting activity. Six categories of total score: inactive (range: 0-2), occasional (range: 3-5), light (range: 6-8), moderate (range: 9-12), moderately vigorous (range: 13-20), and vigorous (\>=21). Higher total score = higher frequency and intensity of physical activity. |
| Secondary | Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR\^1/3, where RR=RR interval in seconds (60 divided by heart rate). |
| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 | Baseline, Week 12, 28, 52 | Assesses positive and negative symptoms, general psychopathology specifically associated with schizophrenia. Scale consists of 30 items, each rated on scale from 1 (symptom not present) - 7 (symptoms extremely severe). Sum of 30 items is defined as PANSS total score, range:30-210. 7 items make up positive scale (delusions, conceptual disorganization, hallucinatory behavior); total range: 7-49. 7 items make up negative scale (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); total range: 7-49. For each subscale, total score: higher score=greater severity. |
| Secondary | Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52 | Baseline, Week 12, 28, 52 | CGI-S is a single-item, clinician-rated scale that assesses the global severity of the participants overall illness. CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill participants). |
| Secondary | Clinical Global Impression-Improvement (CGI-I) Scale Score | Endpoint (premature discontinuation or Week 52) | CGI-I is a single-item, clinician-rated scale that assesses global improvement in the participants clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 to 7, where 1=very much improved, 4=no change and 7=very much worse. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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