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Trial record 45 of 858 for:    ALBUTEROL

A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma

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: NCT01058863
Recruitment Status : Completed
First Posted : January 29, 2010
Results First Posted : June 8, 2015
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Albuterol Spiromax®
Drug: ProAir® HFA
Other: Placebo Inhaler
Enrollment 72
Recruitment Details  
Pre-assignment Details A total of 163 patients were screened and 72 patients were randomized. Most screening failures did not qualify for the study based on reversibility or spirometry criteria.
Arm/Group Title All Randomized Participants
Hide Arm/Group Description Participants were randomized to one of ten treatment sequences, which indicated the order of the 5 single-dose treatments administered in this 5-way crossover study.
Period Title: Overall Study
Started 72
Safety and ITT Populations 71 [1]
Treated With Albuterol Spiromax® 90 mcg 68
Treated With Albuterol Spiromax® 180 mcg 68
Treated With ProAir® HFA 90 mcg 70
Treated With ProAir® HFA 180 mcg 68
Treated With Placebo Inhaler 69
Completed 68
Not Completed 4
Reason Not Completed
Lost to Follow-up             1
Withdrawal by Subject             1
Sponsor requested withdrawal             1
Randomized in error             1
[1]
One patient was randomized in error and never received the study drug.
Arm/Group Title Randomized Treated Participants
Hide Arm/Group Description Participants were randomized to one of ten treatment sequences, which indicated the order of the 5 single-dose treatments administered in this 5-way crossover study.
Overall Number of Baseline Participants 71
Hide Baseline Analysis Population Description
Randomized and treated
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants
43.3  (14.78)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants
12 to <18 years 3
18 to 65 years 64
>65 years 4
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
Female
41
  57.7%
Male
30
  42.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants
White 54
Black or African American 16
Asian 1
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants
Not Latino or Hispanic 67
Latino or Hispanic 4
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 71 participants
169.1  (9.49)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 71 participants
89.6  (22.77)
1.Primary Outcome
Title Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6)
Hide Description

FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day.

The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5 and 6 hours after completion of dosing.

Time Frame Day 1 up to Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population: randomized participants who received at least 1 dose of randomized study medication and had at least 1 post-baseline assessment
Arm/Group Title Albuterol Spiromax® 90 mcg Albuterol Spiromax® 180 mcg ProAir® HFA 90 mcg ProAir® HFA 180 mcg Placebo Inhaler
Hide Arm/Group Description:
A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.
A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
Overall Number of Participants Analyzed 68 68 70 68 69
Mean (Standard Error)
Unit of Measure: L*hour
1.21  (0.224) 1.39  (0.224) 1.12  (0.223) 1.33  (0.224) 0.24  (0.224)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol Spiromax® 180 mcg, Placebo Inhaler
Comments Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance at the 0.05 level.
Method ANOVA
Comments Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.88 to 1.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.136
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Albuterol Spiromax® 90 mcg, Placebo Inhaler
Comments Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance at the 0.05 level.
Method ANOVA
Comments Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.70 to 1.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.136
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ProAir® HFA 180 mcg, Placebo Inhaler
Comments Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level..
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance at the 0.05 level.
Method ANOVA
Comments Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.81 to 1.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.136
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ProAir® HFA 90 mcg, Placebo Inhaler
Comments Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance at the 0.05 level.
Method ANOVA
Comments Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.61 to 1.15
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.136
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Baseline-adjusted Percent-Predicted Forced Expiratory Volume in 1 Second (PPFEV1) Area Under the Curve (AUC 0-6)
Hide Description

Percent-predicted FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. Percent-predicted FEV1 is the expected FEV1 taking into account age, height, gender and race, as per the National Health and Nutrition Examination Survey III (NHANES III) reference values.

The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5 and 6 hours after completion of dosing.

Time Frame Day 1 up to Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population: randomized participants who received at least 1 dose of randomized study medication and had at least 1 post-baseline assessment
Arm/Group Title Albuterol Spiromax® 90 mcg Albuterol Spiromax® 180 mcg ProAir® HFA 90 mcg ProAir® HFA 180 mcg Placebo Inhaler
Hide Arm/Group Description:
A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.
A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
Overall Number of Participants Analyzed 68 68 70 68 69
Mean (Standard Error)
Unit of Measure: % predicted * hour
35.31  (4.497) 41.05  (4.495) 33.19  (4.461) 40.68  (4.496) 7.58  (4.482)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol Spiromax® 180 mcg, Placebo Inhaler
Comments Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance at the 0.05 level.
Method ANOVA
Comments Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 33.47
Confidence Interval (2-Sided) 95%
26.21 to 40.74
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.690
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Albuterol Spiromax® 90 mcg, Placebo Inhaler
Comments Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Significance at the 0.05 level.
Method ANOVA
Comments Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 27.73
Confidence Interval (2-Sided) 95%
20.47 to 34.99
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.686
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ProAir® HFA 180 mcg, Placebo Inhaler
Comments Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance at the 0.05 level.
Method ANOVA
Comments Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 33.10
Confidence Interval (2-Sided) 95%
25.84 to 40.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.686
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ProAir® HFA 90 mcg, Placebo Inhaler
Comments Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance at the 0.05 level.
Method ANOVA
Comments Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 25.61
Confidence Interval (2-Sided) 95%
18.36 to 32.85
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.680
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Participants With Treatment-Emergent Adverse Events
Hide Description Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Time Frame Day 1 up to Day 37
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population of all randomized participants who received at least one dose of randomized study medication.
Arm/Group Title All Randomized Participants
Hide Arm/Group Description:
Participants were randomized to one of five treatment arms, which indicated the order of the 5 single-dose treatments administered in this 5-way crossover study.
Overall Number of Participants Analyzed 71
Measure Type: Number
Unit of Measure: participants
Any adverse event 9
Treatment-related AE 0
Withdrawn from study due to AEs 0
Any serious AEs 0
Treatment-related serious AE 0
Onset treatment for AE: Placebo Inhaler 2
Onset treatment for AE: Albuterol Spiromax 90mcg 3
Onset treatment for AE: Albuterol Spiromax 180mcg 3
Onset treatment for AE: ProAir HFA 90 mcg 0
Onset treatment for AE: ProAir HFA 180 mcg 2
Time Frame Day 1 to Day 37
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Albuterol Spiromax® 90 mcg Albuterol Spiromax® 180 mcg ProAir® HFA 90 mcg ProAir® HFA 180 mcg Placebo Inhaler
Hide Arm/Group Description A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind. A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind. A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind. A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind. Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
All-Cause Mortality
Albuterol Spiromax® 90 mcg Albuterol Spiromax® 180 mcg ProAir® HFA 90 mcg ProAir® HFA 180 mcg Placebo Inhaler
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Albuterol Spiromax® 90 mcg Albuterol Spiromax® 180 mcg ProAir® HFA 90 mcg ProAir® HFA 180 mcg Placebo Inhaler
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/68 (0.00%)   0/68 (0.00%)   0/70 (0.00%)   0/68 (0.00%)   0/69 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Albuterol Spiromax® 90 mcg Albuterol Spiromax® 180 mcg ProAir® HFA 90 mcg ProAir® HFA 180 mcg Placebo Inhaler
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/68 (4.41%)   3/68 (4.41%)   0/70 (0.00%)   2/68 (2.94%)   2/69 (2.90%) 
General disorders           
Cyst  1  1/68 (1.47%)  0/68 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Immune system disorders           
Hypersensitivity  1  0/68 (0.00%)  0/68 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  1/69 (1.45%) 
Food allergy  1  1/68 (1.47%)  0/68 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Infections and infestations           
Localized infection  1  0/68 (0.00%)  0/68 (0.00%)  0/70 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Upper respiratory tract infection  1  1/68 (1.47%)  0/68 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Viral infection  1  0/68 (0.00%)  0/68 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  1/69 (1.45%) 
Injury, poisoning and procedural complications           
Thermal burn  1  0/68 (0.00%)  1/68 (1.47%)  0/70 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Nervous system disorders           
Migraine  1  0/68 (0.00%)  0/68 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  1/69 (1.45%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  0/68 (0.00%)  1/68 (1.47%)  0/70 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Dysphonia  1  0/68 (0.00%)  0/68 (0.00%)  0/70 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Vascular disorders           
Hypertension  1  0/68 (0.00%)  1/68 (1.47%)  0/70 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
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.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor’s review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor’s designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
EMail: ustevatrials@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01058863     History of Changes
Other Study ID Numbers: ABS-AS-201
First Submitted: January 27, 2010
First Posted: January 29, 2010
Results First Submitted: May 19, 2015
Results First Posted: June 8, 2015
Last Update Posted: May 26, 2016