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Trial record 44 of 948 for:    tablet | Japan

Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01004614
Recruitment Status : Completed
First Posted : October 30, 2009
Results First Posted : January 4, 2012
Last Update Posted : January 4, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Intervention Drug: Amlodipine
Enrollment 48
Recruitment Details Participants were screened at one center in Japan.
Pre-assignment Details This study consisted of 2 cohorts (I and II). The design of each cohort was an open-label, randomized, 2-periods, crossover, single-dose study in healthy adult male subjects. A washout period of at least 14 days was taken between each administration in Periods 1 and 2.
Arm/Group Title 3rd OD Tablet With Water, Then 2nd OD Tablet With Water 2nd OD Tablet With Water, Then 3rd OD Tablet With Water 3rd OD Tablet Without Water, Then 2nd OD Tablet Without Water 2nd OD Tablet Without Water, Then 3rd OD Tablet Without Water
Hide Arm/Group Description One amlodipine third generation orally disintegrating (OD) 5 mg tablet (test) taken with water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken with water during second intervention period. A washout of 14 days was retained between periods. One amlodipine second generation OD 5 mg tablet (reference) taken with water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken with water during the second intervention period. A washout of 14 days was retained between periods. One amlodipine third generation OD 5 mg tablet (test) taken without water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken without water during the second intervention period. A washout of 14 days was retained between periods. One amlodipine second generation OD 5mg tablet (reference) taken without water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken without water during the second intervention period. A washout of 14 days was retained between periods.
Period Title: First Intervention
Started 12 12 12 12
Completed 12 12 12 12
Not Completed 0 0 0 0
Period Title: Washout
Started 12 12 12 12
Completed 12 11 12 12
Not Completed 0 1 0 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0
Period Title: Second Intervention
Started 12 11 12 12
Completed 12 11 12 12
Not Completed 0 0 0 0
Arm/Group Title 3rd OD Tablet With Water, Then 2nd OD Tablet With Water 2nd OD Tablet With Water, Then 3rd OD Tablet With Water 3rd OD Tablet Without Water, Then 2nd OD Tablet Without Water 2nd OD Tablet Without Water, Then 3rd OD Tablet Without Water Total
Hide Arm/Group Description One amlodipine third generation orally disintegrating (OD) 5 mg tablet (test) taken with water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken with water during the second intervention period. A washout of 14 days was retained between periods. One amlodipine second generation OD 5mg tablet (reference) taken with water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken with water during the second intervention period. A washout of 14 days was retained between periods. One amlodipine third generation OD 5 mg tablet (test) taken without water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken without water during the second intervention period. A washout of 14 days was retained between periods. One amlodipine second generation OD 5mg tablet (reference) taken without water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken without water during the second intervention period. A washout of 14 days was retained between periods. Total of all reporting groups
Overall Number of Baseline Participants 12 12 12 12 48
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
33.8  (10.7) 32.4  (11.1) 37.3  (9.0) 37.8  (12.1) 33.1  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
12
 100.0%
12
 100.0%
12
 100.0%
12
 100.0%
48
 100.0%
1.Primary Outcome
Title Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt)
Hide Description Area under the concentration-time curve from zero time until the last sampling time
Time Frame prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.
Arm/Group Title Cohort I: 3rd OD Tablet (Test) With Water Cohort I: 2nd OD Tablet (Reference) With Water Cohort II: 3rd OD Tablet (Test) Without Water Cohort II: 2nd OD Tablet (Reference) Without Water
Hide Arm/Group Description:
Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
Overall Number of Participants Analyzed 23 23 24 24
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
126.36  (33.16) 129.48  (39.93) 122.33  (32.59) 119.75  (28.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort I: 3rd OD Tablet (Test) With Water, Cohort I: 2nd OD Tablet (Reference) With Water, Cohort II: 3rd OD Tablet (Test) Without Water, Cohort II: 2nd OD Tablet (Reference) Without Water
Comments Natural log transformed AUCt was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL <=µT - µR <=θU); null hypothesis of inequivalence: (Ho: µT - µR <θL or µT - µR >θU).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).
Method of Estimation Estimation Parameter ratios of adjusted geometric mean
Estimated Value 98.61
Confidence Interval (2-Sided) 90%
93.09 to 104.46
Estimation Comments Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort I: 3rd OD Tablet (Test) With Water, Cohort I: 2nd OD Tablet (Reference) With Water, Cohort II: 3rd OD Tablet (Test) Without Water, Cohort II: 2nd OD Tablet (Reference) Without Water
Comments Natural log transformed AUCt was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL <=µT - µR <=θU); null hypothesis of inequivalence: (Ho: µT - µR <θL or µT - µR >θU).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).
Method of Estimation Estimation Parameter ratios of adjusted geometric mean
Estimated Value 101.29
Confidence Interval (2-Sided) 90%
97.28 to 105.45
Estimation Comments Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.
2.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description [Not Specified]
Time Frame prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.
Arm/Group Title Cohort I: 3rd OD Tablet (Test) With Water Cohort I: 2nd OD Tablet (Reference) With Water Cohort II: 3rd OD Tablet (Test) Without Water Cohort II: 2nd OD Tablet (Reference) Without Water
Hide Arm/Group Description:
Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
Overall Number of Participants Analyzed 23 23 24 24
Mean (Standard Deviation)
Unit of Measure: ng/mL
2.70  (0.513) 2.74  (0.650) 2.48  (0.470) 2.45  (0.409)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort I: 3rd OD Tablet (Test) With Water, Cohort I: 2nd OD Tablet (Reference) With Water, Cohort II: 3rd OD Tablet (Test) Without Water, Cohort II: 2nd OD Tablet (Reference) Without Water
Comments Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL <=µT - µR <=θU); null hypothesis of inequivalence: (Ho: µT - µR <θL or µT - µR >θU).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).
Method of Estimation Estimation Parameter ratios of adjusted geometric mean
Estimated Value 99.30
Confidence Interval (2-Sided) 90%
92.28 to 106.28
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort I: 3rd OD Tablet (Test) With Water, Cohort I: 2nd OD Tablet (Reference) With Water, Cohort II: 3rd OD Tablet (Test) Without Water, Cohort II: 2nd OD Tablet (Reference) Without Water
Comments Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL <=µT - µR <=θU); null hypothesis of inequivalence: (Ho: µT - µR <θL or µT - µR >θU).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).
Method of Estimation Estimation Parameter ratios of adjusted geometric mean
Estimated Value 100.84
Confidence Interval (2-Sided) 90%
95.93 to 106.00
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast), Area Under the Plasma Concentration-Time Curve to Infinity (AUCinf)
Hide Description

AUC last = Area under the concentration versus time curve from zero time until the last measurable concentration is calculated using the trapezoidal rule.

AUCinf = AUClast + (Ct / kel), where Ct is the estimated concentration at the last measurable concentration.

Time Frame prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.
Arm/Group Title Cohort I: 3rd OD Tablet (Test) With Water Cohort I: 2nd OD Tablet (Reference) With Water Cohort II: 3rd OD Tablet (Test) Without Water Cohort II: 2nd OD Tablet (Reference) Without Water
Hide Arm/Group Description:
Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
Overall Number of Participants Analyzed 23 23 24 24
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
AUClast 124.14  (33.96) 127.36  (40.91) 121.05  (33.76) 118.27  (29.43)
AUCinf 142.87  (43.20) 145.22  (49.19) 140.41  (42.18) 138.14  (34.10)
4.Secondary Outcome
Title Apparent Terminal Elimination Phase Rate Constant (Kel)
Hide Description Estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile.
Time Frame prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.
Arm/Group Title Cohort I: 3rd OD Tablet (Test) With Water Cohort I: 2nd OD Tablet (Reference) With Water Cohort II: 3rd OD Tablet (Test) Without Water Cohort II: 2nd OD Tablet (Reference) Without Water
Hide Arm/Group Description:
Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
Overall Number of Participants Analyzed 23 23 24 24
Mean (Standard Deviation)
Unit of Measure: L/h
0.0174  (0.0031) 0.0179  (0.0035) 0.0162  (0.0041) 0.0156  (0.0031)
5.Secondary Outcome
Title Apparent Terminal Elimination Half-Life (T-half)
Hide Description Terminal phase half-life calculated as ln(2) / kel
Time Frame prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.
Arm/Group Title Cohort I: 3rd OD Tablet (Test) With Water Cohort I: 2nd OD Tablet (Reference) With Water Cohort II: 3rd OD Tablet (Test) Without Water Cohort II: 2nd OD Tablet (Reference) Without Water
Hide Arm/Group Description:
Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
Overall Number of Participants Analyzed 23 23 24 24
Mean (Standard Deviation)
Unit of Measure: hour
41.45  (9.76) 40.27  (8.48) 45.04  (10.16) 46.20  (8.85)
6.Secondary Outcome
Title Mean Residence Time (MRT)
Hide Description MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from zero time to infinity calculated as AUMCinf = AUMCt + ((t x Ct) / kel) + (Ct / kel^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method.
Time Frame prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.
Arm/Group Title Cohort I: 3rd OD Tablet (Test) With Water Cohort I: 2nd OD Tablet (Reference) With Water Cohort II: 3rd OD Tablet (Test) Without Water Cohort II: 2nd OD Tablet (Reference) Without Water
Hide Arm/Group Description:
Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
Overall Number of Participants Analyzed 23 23 24 24
Mean (Standard Deviation)
Unit of Measure: hour
61.29  (13.55) 59.77  (11.99) 66.18  (14.10) 67.33  (11.90)
7.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax)
Hide Description [Not Specified]
Time Frame prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.
Arm/Group Title Cohort I: 3rd OD Tablet (Test) With Water Cohort I: 2nd OD Tablet (Reference) With Water Cohort II: 3rd OD Tablet (Test) Without Water Cohort II: 2nd OD Tablet (Reference) Without Water
Hide Arm/Group Description:
Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
Overall Number of Participants Analyzed 23 23 24 24
Median (Full Range)
Unit of Measure: hour
8
(4 to 12)
8
(4 to 12)
8
(6 to 12)
8
(6 to 12)
Time Frame [Not Specified]
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 Cohort I: 3rd OD Tablet (Test) With Water Cohort I: 2nd OD Tablet (Reference) With Water Cohort II: 3rd OD Tablet (Test) Without Water Cohort II: 2nd OD Tablet (Reference) Without Water
Hide Arm/Group Description Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
All-Cause Mortality
Cohort I: 3rd OD Tablet (Test) With Water Cohort I: 2nd OD Tablet (Reference) With Water Cohort II: 3rd OD Tablet (Test) Without Water Cohort II: 2nd OD Tablet (Reference) Without Water
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort I: 3rd OD Tablet (Test) With Water Cohort I: 2nd OD Tablet (Reference) With Water Cohort II: 3rd OD Tablet (Test) Without Water Cohort II: 2nd OD Tablet (Reference) Without Water
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/24 (0.00%)   0/24 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort I: 3rd OD Tablet (Test) With Water Cohort I: 2nd OD Tablet (Reference) With Water Cohort II: 3rd OD Tablet (Test) Without Water Cohort II: 2nd OD Tablet (Reference) Without Water
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/23 (30.43%)   6/24 (25.00%)   2/24 (8.33%)   3/24 (12.50%) 
Gastrointestinal disorders         
Abdominal discomfort  1  1/23 (4.35%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%) 
Diarrhoea  1  0/23 (0.00%)  0/24 (0.00%)  1/24 (4.17%)  0/24 (0.00%) 
Stomatitis  1  0/23 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  1/24 (4.17%) 
Toothache  1  1/23 (4.35%)  1/24 (4.17%)  0/24 (0.00%)  0/24 (0.00%) 
Infections and infestations         
Pharingitis  1  1/23 (4.35%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%) 
Investigations         
Blood bilirubin increased  1  0/23 (0.00%)  1/24 (4.17%)  0/24 (0.00%)  0/24 (0.00%) 
Blood uric acid increased  1  0/23 (0.00%)  1/24 (4.17%)  0/24 (0.00%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscular weakness  1  1/23 (4.35%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%) 
Musculoskeletal stiffness  1  1/23 (4.35%)  1/24 (4.17%)  0/24 (0.00%)  0/24 (0.00%) 
Nervous system disorders         
Headache  1  2/23 (8.70%)  1/24 (4.17%)  0/24 (0.00%)  1/24 (4.17%) 
Somnolence  1  0/23 (0.00%)  0/24 (0.00%)  1/24 (4.17%)  1/24 (4.17%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal disconfort  1  1/23 (4.35%)  1/24 (4.17%)  0/24 (0.00%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01004614     History of Changes
Other Study ID Numbers: A0531088
First Submitted: October 29, 2009
First Posted: October 30, 2009
Results First Submitted: December 3, 2010
Results First Posted: January 4, 2012
Last Update Posted: January 4, 2012