One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome
Study Details
Study Description
Brief Summary
The purpose of this study is to explore the impact of Ziprasidone HCl on the distribution of metabolic syndrome (MS) risk factors in a population of Bipolar patients presenting with glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their current antipsychotic medication.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
The trial was terminated prematurely on December 14, 2010, due to inability to recruit the planned number of subjects and shifting organizational priorities. The decision to terminate the trial was not based on any safety or efficacy concerns.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Active treatment (switch to oral Ziprasidone)
|
Drug: Ziprasidone HCL (oral)
Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40-160 mg total daily dose) for up to 1 year.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Who Achieved a Reduction From Baseline of at Least 1 Risk Factor for Metabolic Syndrome (MS) at Week 52 or Premature Discontinuation [Week 52 or Early Termination]
MS risks factors: elevated (el) waist circumference: ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); el triglycerides: ≥1.7 millimoles per liter (mmol/L) (1≥50 milligrams per deciliter [mg/dL]); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; el fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and el systolic/diastolic blood pressure: systolic ≥130 millimeters of mercury (mmHg) and/or diastolic ≥85 mmHg. Responder = at least 1 less risk factor at endpoint than baseline.
Secondary Outcome Measures
- Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) [Baseline, Week 52]
MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.
- Metabolic Syndrome (MS) Prevalence [Baseline through Week 52]
Percentage of participants at each visit defined as having metabolic syndrome (MS) based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel III. MS = 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose.
- Change From Baseline in the Percentage of Participants With Each Individual Metabolic Syndrome (MS) Risk Factor [Baseline through Week 52]
MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.
- Percentage of Participants With Individual Metabolic Syndrome (MS) Risk Factors [Baseline through Week 52]
MS risks factors = elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.
- Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Waist Circumference [Baseline, Week 4, Week 12, Week 52]
MS risk factor elevated waist circumference defined as ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]).
- Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Systolic/Diastolic Blood Pressure [Baseline, Week 4, Week 12, Week 52]
MS risk factor elevated systolic/diastolic blood pressure defined as systolic blood pressure ≥130 millimeters of mercury (mm Hg) and/or diastolic blood pressure ≥85 mm Hg.
- Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Fasting Glucose [Baseline, Week 4, Week 12, Week 52]
MS risk factor elevated fasting glucose defined as ≥5.6 millimoles per liter (mmol/L) (≥100 mg/dL).
- Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Reduced High-density Lipoprotein Cholesterol (HDL-C) [Baseline, Week 4, Week 12, Week 52]
MS risk factor reduced HDL-C defined as <1.03 millimoles per liter (mmol/L) (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women.
- Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Triglycerides [Baseline, Week 4, Week 12, Week 52]
MS risk factor elevated triglycerides defined as ≥1.7 millimoles per liter (mmol/L) (1≥50 mg/dL).
- Change From Baseline in Ten-year Coronary Heart Disease (CHD) Risk According to Framingham Scoring System [Baseline, Week 4, Week 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 10 year risk (range <1% to ≥30% 10 year risk).
- Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels [Baseline, Week 52 or Early Termination]
- Change From Baseline in Weight [Baseline, Week 4, Week 12, Week 52 or Early Termination]
- Change From Baseline in Body Mass Index (BMI) [Baseline, Week 4, Week 12, Week 52 or Early Termination]
Body mass index = weight in kilograms (kg) / height in meters (m)^2 .
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) [Baseline, Week 52 or Early Termination]
- Change From Baseline in Insulin Levels [Baseline, Week 52 or Early Termination]
- Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF) [Baseline, Week 4, Week 52 or Early Termination]
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.
- Change From Baseline in Apolipoprotein B (ApoB) Levels [Baseline, Week 52 or Early Termination]
- Change From Baseline in Leptin [Baseline, Week 52 or Early Termination]
- Change From Baseline in Physical Activity Index [Baseline, Week 28, Week 52 or Early Termination]
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 score = higher frequency and intensity of physical activity.
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score [Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination]
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
- Change From Baseline in Young Mania Rating Scale (YMRS) [Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination]
11-item scale that measures the severity of manic episodes from subject reported symptoms over previous 48 hours and clinical observation during interview. Four items (irritability, speech, thought content, disruptive-aggressive behaviour) are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining 7 items (elevated mood, increased motor activity-energy, sexual interest, sleep, language-thought disorder, appearance, insight) are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). YMRS total score range = 0 to 60.
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Subscale [Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination]
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
- Clinical Global Impression - Improvement (CGI-I) Subscale Score [Week 52 or Early Termination]
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
- Change From Baseline in Drug Attitude Inventory (DAI) [Week 28, Week 52 or Early Termination]
DAI, a 10-item scale to assess how the attitude of schizophrenia participants toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranged from -10 to 10, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. Change: score at observation minus score at baseline.
- Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) [Baseline, Week 28, Week 52 or Early Termination]
0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning. 1 to 10 = persistent inability to maintain minimal personal hygiene; unable to function without harming self or others or without considerable external support; 91 to 100 = superior functioning in a wide range of activities.
- Change From Baseline in EuroQoL Index (EQ-I) [Baseline, Week 28, Week 52 or Early Termination]
EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
- Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score [Baseline, Week 28, Week 52 or Early Termination]
EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
- Change From Baseline in Impact of Weight on Quality of Life-Lite Version (IWQOL-Lite) Scale [Baseline, Week 28, Week 52 or Early Termination]
31-item self report inventory to assess impact of weight on quality of life. Five subscales: physical functioning, self-esteem, sexual life, public distress, and work, with categories in each subscale scored 1 (no trouble or difficulty) to 5 (persistent trouble or difficulty). The rescaled IWQoL-Lite score is determined by the sum of scores on all 31 items and rescaling this sum to a 1 to 100 scoring with 0=the poorest and 100=the best quality of life.
- Number of Participants With Suicidal Tendencies (Columbian-Suicide Severity Rating Scale, [C-SSRS], Mapped to C-CASA [Columbia Classification Algorithm For Suicide Assessment]) [Baseline, Week 1 through Week 52 or Early Termination]
C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject must present at least 2 of the following risk factors of MS at screening: Elevated waist circumference: >102 cm in men and >88 cm in women; Elevated triglycerides (TGs): ≥1.7 mmol/L (≥150 mg/dL); Reduced HDL-Cholesterol: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; Elevated fasting glucose: ≥ 5.6 mmol/L.
-
According to the clinical judgment of the investigator, the risk factors for MS have developed in close temporal relationship to starting an antipsychotic medication.
-
Substitution to a less metabolically disruptive antipsychotic medication is considered
Exclusion Criteria:
-
Subjects with contraindication(s) to the use of Ziprasidone according to Canadian prescribing information.
-
Subjects with a history of treatment resistance.
-
Subjects with any medical condition (e.g. pre-existing diabetes, pre-existing dyslipidemia, thyroid pathology) or taking any concomitant medication (e.g. topiramate or other weight loss-promoting agents, hypoglycemic agents, hypolipemic agents), that may confound the evaluation of the study drug.
-
Body mass index ≥ 40 at baseline.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Foothills Medical Centre, Department of Psychiatry | Calgary | Alberta | Canada | T2N 2T9 |
2 | Mental Health Centre for Research and Education | Calgary | Alberta | Canada | T2N 2T9 |
3 | Dr. Alexander McIntyre Inc. | Penticton | British Columbia | Canada | V2A 4M4 |
4 | Country Club Plaza | Winnipeg | Manitoba | Canada | R3K 2E2 |
5 | Edgeland Medical, Dr. Alla Kirshner Medical Corporation | Winnipeg | Manitoba | Canada | R3P 0N5 |
6 | Capital, Health Authority, QE II Health Sciences Centre, Mood Disorder Clinic | Halifax | Nova Scotia | Canada | B3H 2E2 |
7 | Office of Dr. A. K. Munshi | Sydney | Nova Scotia | Canada | B1S 2E8 |
8 | Centre de recherche Fernand-Seguin de l'hopital Louis H. Lafontaine | Montreal | Quebec | Canada | H1N 3V2 |
9 | Clinique St-Leonard | Montreal | Quebec | Canada | H1P 3K2 |
10 | Diex Research Sherbrooke Inc. | Sherbrooke | Quebec | Canada | J1H 1Z1 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A1281190
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | Twenty-seven participants were screened for the study and 13 participants were assigned to study drug and treated. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Period Title: Overall Study | |
STARTED | 13 |
COMPLETED | 0 |
NOT COMPLETED | 13 |
Baseline Characteristics
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Overall Participants | 13 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
46.5
(10.7)
|
Sex: Female, Male (Count of Participants) | |
Female |
9
69.2%
|
Male |
4
30.8%
|
Outcome Measures
Title | Percentage of Participants Who Achieved a Reduction From Baseline of at Least 1 Risk Factor for Metabolic Syndrome (MS) at Week 52 or Premature Discontinuation |
---|---|
Description | MS risks factors: elevated (el) waist circumference: ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); el triglycerides: ≥1.7 millimoles per liter (mmol/L) (1≥50 milligrams per deciliter [mg/dL]); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; el fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and el systolic/diastolic blood pressure: systolic ≥130 millimeters of mercury (mmHg) and/or diastolic ≥85 mmHg. Responder = at least 1 less risk factor at endpoint than baseline. |
Time Frame | Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
Per protocol population: all subjects in the intent-to-treat population who remained in the study for at least 28 weeks. N = number of participants with analyzable data at observation. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 10 |
Number [percentage of participants] |
50.00
384.6%
|
Title | Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) |
---|---|
Description | MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg. |
Time Frame | Baseline, Week 52 |
Outcome Measure Data
Analysis Population Description |
---|
PP and Intent-to-treat (ITT) population; ITT population = all participants enrolled in the study who received at least 1 dose of study medication and who had baseline and at least 1 post-baseline MS measurement. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Metabolic Syndrome (MS) Prevalence |
---|---|
Description | Percentage of participants at each visit defined as having metabolic syndrome (MS) based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel III. MS = 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose. |
Time Frame | Baseline through Week 52 |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in the Percentage of Participants With Each Individual Metabolic Syndrome (MS) Risk Factor |
---|---|
Description | MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg. |
Time Frame | Baseline through Week 52 |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Percentage of Participants With Individual Metabolic Syndrome (MS) Risk Factors |
---|---|
Description | MS risks factors = elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg. |
Time Frame | Baseline through Week 52 |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Waist Circumference |
---|---|
Description | MS risk factor elevated waist circumference defined as ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]). |
Time Frame | Baseline, Week 4, Week 12, Week 52 |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Systolic/Diastolic Blood Pressure |
---|---|
Description | MS risk factor elevated systolic/diastolic blood pressure defined as systolic blood pressure ≥130 millimeters of mercury (mm Hg) and/or diastolic blood pressure ≥85 mm Hg. |
Time Frame | Baseline, Week 4, Week 12, Week 52 |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Fasting Glucose |
---|---|
Description | MS risk factor elevated fasting glucose defined as ≥5.6 millimoles per liter (mmol/L) (≥100 mg/dL). |
Time Frame | Baseline, Week 4, Week 12, Week 52 |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Reduced High-density Lipoprotein Cholesterol (HDL-C) |
---|---|
Description | MS risk factor reduced HDL-C defined as <1.03 millimoles per liter (mmol/L) (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women. |
Time Frame | Baseline, Week 4, Week 12, Week 52 |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Triglycerides |
---|---|
Description | MS risk factor elevated triglycerides defined as ≥1.7 millimoles per liter (mmol/L) (1≥50 mg/dL). |
Time Frame | Baseline, Week 4, Week 12, Week 52 |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in Ten-year Coronary Heart Disease (CHD) Risk According to Framingham Scoring System |
---|---|
Description | 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 10 year risk (range <1% to ≥30% 10 year risk). |
Time Frame | Baseline, Week 4, Week 52 |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels |
---|---|
Description | |
Time Frame | Baseline, Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Median was reported due to small sample size and risk of skewing. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 10 |
Total cholesterol: Baseline |
206.0
|
Total cholesterol: Change at Last Observation |
-20.0
|
LDL cholesterol: Baseline |
131.0
|
LDL cholesterol: Change at Last Observation |
-8.0
|
Title | Change From Baseline in Weight |
---|---|
Description | |
Time Frame | Baseline, Week 4, Week 12, Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT; n = number of participants with evaluable data at observation. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 13 |
Baseline (n=13) |
93.5
(23.12)
|
Value at Week 4 (n=9) |
92.9
(21.99)
|
Value at Week 12 (n=5) |
97.3
(25.37)
|
Value at Week 52 (n=10) |
87.5
(24.50)
|
Title | Change From Baseline in Body Mass Index (BMI) |
---|---|
Description | Body mass index = weight in kilograms (kg) / height in meters (m)^2 . |
Time Frame | Baseline, Week 4, Week 12, Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results for BMI not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in Glycosylated Hemoglobin (HbA1c) |
---|---|
Description | |
Time Frame | Baseline, Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Median was reported due to small sample size and risk of skewing. Last observation = last observation while on study drug or during the lag. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 10 |
Baseline |
5.5
|
Median change |
-0.2
|
Title | Change From Baseline in Insulin Levels |
---|---|
Description | |
Time Frame | Baseline, Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Insulin levels not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF) |
---|---|
Description | 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. |
Time Frame | Baseline, Week 4, Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT; n = number of participants with analyzable data at observation. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 13 |
Baseline (n=13) |
421.0
(12.16)
|
Week 4 (n=9) |
434.0
(13.61)
|
Week 52 or or Early Termination (n=9) |
428.8
(14.65)
|
Title | Change From Baseline in Apolipoprotein B (ApoB) Levels |
---|---|
Description | |
Time Frame | Baseline, Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in Leptin |
---|---|
Description | |
Time Frame | Baseline, Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in Physical Activity Index |
---|---|
Description | 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 score = higher frequency and intensity of physical activity. |
Time Frame | Baseline, Week 28, Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score |
---|---|
Description | Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). |
Time Frame | Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in Young Mania Rating Scale (YMRS) |
---|---|
Description | 11-item scale that measures the severity of manic episodes from subject reported symptoms over previous 48 hours and clinical observation during interview. Four items (irritability, speech, thought content, disruptive-aggressive behaviour) are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining 7 items (elevated mood, increased motor activity-energy, sexual interest, sleep, language-thought disorder, appearance, insight) are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). YMRS total score range = 0 to 60. |
Time Frame | Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Subscale |
---|---|
Description | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. |
Time Frame | Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Clinical Global Impression - Improvement (CGI-I) Subscale Score |
---|---|
Description | CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. |
Time Frame | Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in Drug Attitude Inventory (DAI) |
---|---|
Description | DAI, a 10-item scale to assess how the attitude of schizophrenia participants toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranged from -10 to 10, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. Change: score at observation minus score at baseline. |
Time Frame | Week 28, Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) |
---|---|
Description | 0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning. 1 to 10 = persistent inability to maintain minimal personal hygiene; unable to function without harming self or others or without considerable external support; 91 to 100 = superior functioning in a wide range of activities. |
Time Frame | Baseline, Week 28, Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in EuroQoL Index (EQ-I) |
---|---|
Description | EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
Time Frame | Baseline, Week 28, Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score |
---|---|
Description | EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. |
Time Frame | Baseline, Week 28, Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Change From Baseline in Impact of Weight on Quality of Life-Lite Version (IWQOL-Lite) Scale |
---|---|
Description | 31-item self report inventory to assess impact of weight on quality of life. Five subscales: physical functioning, self-esteem, sexual life, public distress, and work, with categories in each subscale scored 1 (no trouble or difficulty) to 5 (persistent trouble or difficulty). The rescaled IWQoL-Lite score is determined by the sum of scores on all 31 items and rescaling this sum to a 1 to 100 scoring with 0=the poorest and 100=the best quality of life. |
Time Frame | Baseline, Week 28, Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Title | Number of Participants With Suicidal Tendencies (Columbian-Suicide Severity Rating Scale, [C-SSRS], Mapped to C-CASA [Columbia Classification Algorithm For Suicide Assessment]) |
---|---|
Description | C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category. |
Time Frame | Baseline, Week 1 through Week 52 or Early Termination |
Outcome Measure Data
Analysis Population Description |
---|
PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. |
Arm/Group Title | Ziprasidone |
---|---|
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
Measure Participants | 0 |
Adverse Events
Time Frame | ||
---|---|---|
Adverse Event Reporting Description | The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. | |
Arm/Group Title | Ziprasidone | |
Arm/Group Description | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. | |
All Cause Mortality |
||
Ziprasidone | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Ziprasidone | ||
Affected / at Risk (%) | # Events | |
Total | 1/13 (7.7%) | |
Nervous system disorders | ||
Akathisia | 1/13 (7.7%) | |
Other (Not Including Serious) Adverse Events |
||
Ziprasidone | ||
Affected / at Risk (%) | # Events | |
Total | 13/13 (100%) | |
Ear and labyrinth disorders | ||
Vertigo | 1/13 (7.7%) | |
Gastrointestinal disorders | ||
Constipation | 1/13 (7.7%) | |
Nausea | 5/13 (38.5%) | |
General disorders | ||
Non-cardiac chest pain | 1/13 (7.7%) | |
Thirst | 1/13 (7.7%) | |
Infections and infestations | ||
Upper respiratory infection | 1/13 (7.7%) | |
Injury, poisoning and procedural complications | ||
Contusion | 1/13 (7.7%) | |
Investigations | ||
Blood cholesterol increased | 1/13 (7.7%) | |
Blood prolactin increased | 1/13 (7.7%) | |
High density lipoprotein decreased | 1/13 (7.7%) | |
Low density lipoprotein increased | 1/13 (7.7%) | |
Protein urine present | 1/13 (7.7%) | |
Musculoskeletal and connective tissue disorders | ||
Back pain | 1/13 (7.7%) | |
Neck pain | 1/13 (7.7%) | |
Pain in jaw | 1/13 (7.7%) | |
Nervous system disorders | ||
Akathisia | 3/13 (23.1%) | |
Disturbance in attention | 1/13 (7.7%) | |
Dizziness | 2/13 (15.4%) | |
Headache | 5/13 (38.5%) | |
Memory impairment | 1/13 (7.7%) | |
Sedation | 1/13 (7.7%) | |
Somnolence | 4/13 (30.8%) | |
Tension headache | 1/13 (7.7%) | |
Psychiatric disorders | ||
Agitation | 2/13 (15.4%) | |
Confusional state | 1/13 (7.7%) | |
Depression | 2/13 (15.4%) | |
Emotional disorder | 1/13 (7.7%) | |
Flat affect | 1/13 (7.7%) | |
Hypomania | 1/13 (7.7%) | |
Insomnia | 6/13 (46.2%) | |
Mania | 1/13 (7.7%) | |
Suicidal ideation | 1/13 (7.7%) | |
Terminal insomnia | 1/13 (7.7%) | |
Reproductive system and breast disorders | ||
Menstruation irregular | 1/13 (7.7%) | |
Respiratory, thoracic and mediastinal disorders | ||
Rhinorrhea | 1/13 (7.7%) | |
Wheezing | 1/13 (7.7%) | |
Skin and subcutaneous tissue disorders | ||
Rash | 1/13 (7.7%) | |
Vascular disorders | ||
Hypertension | 1/13 (7.7%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title | Pfizer ClinicalTrials.gov Call Center |
---|---|
Organization | Pfizer, Inc. |
Phone | 1-800-718-1021 |
ClinicalTrials.gov_Inquiries@pfizer.com |
- A1281190