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Trial record 53 of 143 for:    NIFEDIPINE

Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study

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ClinicalTrials.gov Identifier: NCT00768560
Recruitment Status : Completed
First Posted : October 8, 2008
Results First Posted : February 2, 2010
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Nifedipine (Adalat CR, BAYA1040) 80mg OD
Drug: Nifedipine (Adalat CR, BAYA1040) 40mg BID
Drug: Nifedipine (Adalat CR, BAYA1040) 40mg OD
Enrollment 35
Recruitment Details 47 subjects were recruited from 30 Jan 2008 to 11 May 2008 by 3 centers in Japan.
Pre-assignment Details After a 4-week baseline treatment with Adalat controlled release (CR) 40 mg once daily (OD), 35 subjects were randomized to double-blind treatment and were included in the safety analysis. 34 subjects were included in the analysis of pharmacokinetics, efficacy and demographic data. 1 subject discontinued the study in Period 1 due to adverse event.
Arm/Group Title Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
Period Title: Intervention Set 1
Started 5 [1] 6 [1] 6 [1] 6 [1] 6 [1] 6 [1]
Subjects Received Treatment 5 [2] 6 [2] 6 [3] 6 [4] 6 [5] 6 [5]
Completed 5 5 6 6 6 6
Not Completed 0 1 0 0 0 0
Reason Not Completed
Adverse Event             0             1             0             0             0             0
[1]
3-period/treatment crossover
[2]
40 mg OD for 2 weeks
[3]
40 mg twice daily (BID) for 2 weeks
[4]
40 mg BID for 2 weeks
[5]
80 mg OD for 2 weeks
Period Title: Intervention Set 2
Started 5 [1] 5 [2] 6 [2] 6 [3] 6 [3] 6 [1]
Completed 5 5 6 6 6 6
Not Completed 0 0 0 0 0 0
[1]
40 mg BID for 2 weeks
[2]
80 mg OD for 2 weeks
[3]
40 mg OD for 2 weeks
Period Title: Intervention Set 3
Started 5 [1] 5 [2] 6 [3] 6 [1] 6 [2] 6 [3]
Completed 5 5 6 6 6 6
Not Completed 0 0 0 0 0 0
[1]
80 mg OD for 2 weeks
[2]
40 mg BID for 2 weeks
[3]
40 mg OD for 2 weeks
Arm/Group Title Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 5 5 6 6 6 6 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 6 participants 6 participants 6 participants 6 participants 34 participants
61.4
(55 to 68)
63.6
(55 to 73)
59.7
(55 to 65)
64.3
(60 to 70)
58.2
(37 to 67)
59.7
(56 to 68)
61.1
(37 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 6 participants 6 participants 6 participants 6 participants 34 participants
Female
1
  20.0%
3
  60.0%
0
   0.0%
2
  33.3%
1
  16.7%
1
  16.7%
8
  23.5%
Male
4
  80.0%
2
  40.0%
6
 100.0%
4
  66.7%
5
  83.3%
5
  83.3%
26
  76.5%
Blood Pressure (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 5 participants 5 participants 6 participants 6 participants 6 participants 6 participants 34 participants
SBP at baseline 150.00  (7.91) 161.00  (16.67) 156.33  (11.18) 155.83  (10.96) 156.33  (14.79) 154.83  (13.53) 155.89  (12.38)
DBP at baseline 94.40  (4.98) 95.00  (6.60) 98.00  (6.45) 91.00  (7.07) 92.50  (3.45) 89.83  (7.68) 93.43  (6.40)
[1]
Measure Description: Blood pressure (BP) before the start of baseline treatment. Subjects valid for safety analysis
Heart rate (HR) at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Beats / min
Number Analyzed 5 participants 5 participants 6 participants 6 participants 6 participants 6 participants 34 participants
64.20  (6.18) 72.67  (13.95) 79.00  (10.81) 70.83  (5.42) 68.50  (7.87) 79.50  (17.84) 72.69  (11.83)
[1]
Measure Description: Heart rate (HR) before the start of baseline treatment. Subjects valid for safety analysis
1.Primary Outcome
Title Change of Sitting Blood Pressure
Hide Description Changes of sitting SBP and DBP (trough values) from baseline (ie [trough BP at the end of each period during the double-blind treatment period] minus [trough BP at the end of the baseline treatment period])
Time Frame Baseline and after 2 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol efficacy population: subjects valid for safety analysis who have no critical protocol deviation and have trough BP at the end of baseline treatment period and trough BP at the end of period 1 are considered valid for the analysis.
Arm/Group Title Nifedipine (Adalat CR, BAYA1040) 40 mg OD Nifedipine (Adalat CR, BAYA1040) 40 mg BID Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Hide Arm/Group Description:
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
Overall Number of Participants Analyzed 34 34 34
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
Systolic Blood Pressure -10.19  (1.24) -19.88  (1.24) -10.13  (1.24)
Diastolic Blood Pressure -4.30  (0.65) -8.28  (0.65) -4.98  (0.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nifedipine (Adalat CR, BAYA1040) 40 mg OD, Nifedipine (Adalat CR, BAYA1040) 40 mg BID
Comments The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the analysis of variance (ANOVA) model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.69
Confidence Interval 90%
-12.62 to -6.77
Estimation Comments 40 mg BID minus 40 mg OD
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nifedipine (Adalat CR, BAYA1040) 40 mg OD, Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Comments The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval 90%
-2.87 to 2.98
Estimation Comments 80 mg OD minus 40 mg OD
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Nifedipine (Adalat CR, BAYA1040) 40 mg BID, Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Comments The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.75
Confidence Interval 90%
6.83 to 12.67
Estimation Comments 80 mg OD minus 40 mg BID
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Nifedipine (Adalat CR, BAYA1040) 40 mg OD, Nifedipine (Adalat CR, BAYA1040) 40 mg BID
Comments The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.97
Confidence Interval 90%
-5.50 to -2.44
Estimation Comments 40 mg BID minus 40 mg OD
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Nifedipine (Adalat CR, BAYA1040) 40 mg OD, Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Comments The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.68
Confidence Interval 90%
-2.21 to 0.85
Estimation Comments 80 mg OD minus 40 mg OD
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Nifedipine (Adalat CR, BAYA1040) 40 mg BID, Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Comments The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.29
Confidence Interval 90%
1.76 to 4.82
Estimation Comments 80 mg OD minus 40 mg BID
2.Secondary Outcome
Title Differences of Systolic Blood Pressure Profile
Hide Description Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)
Time Frame Baseline and after 2 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects valid for efficacy analysis
Arm/Group Title Nifedipine (Adalat CR, BAYA1040) 40 mg OD Nifedipine (Adalat CR, BAYA1040) 40 mg BID Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Hide Arm/Group Description:
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
Overall Number of Participants Analyzed 34 34 34
Mean (Standard Deviation)
Unit of Measure: mm Hg
At 0-hour post-dose -11.35  (15.75) -21.24  (11.56) -9.91  (10.58)
At 2-hour post-dose -4.91  (11.62) -8.65  (11.19) -11.97  (10.15)
At 4-hour post-dose -6.18  (12.05) -5.76  (11.25) -7.85  (10.02)
At 6-hour post-dose -6.56  (12.58) -4.94  (9.31) -7.26  (8.40)
At 8-hour post-dose -7.88  (11.53) -6.97  (10.23) -7.88  (10.68)
At 10-hour post-dose -4.79  (10.60) -4.03  (10.64) -6.56  (9.41)
At 12-hour post-dose -5.59  (10.98) -4.38  (9.31) -6.00  (9.98)
At 24-hour post-dose -8.97  (12.79) -18.38  (8.34) -10.21  (10.87)
3.Secondary Outcome
Title Differences of Diastolic Blood Pressure Profile
Hide Description Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)
Time Frame Baseline and after 2 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects valid for efficacy analysis
Arm/Group Title Nifedipine (Adalat CR, BAYA1040) 40 mg OD Nifedipine (Adalat CR, BAYA1040) 40 mg BID Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Hide Arm/Group Description:
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
Overall Number of Participants Analyzed 34 34 34
Mean (Standard Deviation)
Unit of Measure: mm Hg
At 0-hour post-dose -3.82  (6.40) -8.12  (6.24) -4.18  (5.54)
At 2-hour post-dose -4.15  (7.27) -5.47  (7.01) -7.18  (5.89)
At 4-hour post dose -3.44  (7.47) -1.62  (8.11) -3.68  (6.33)
At 6-hour post-dose -5.56  (7.42) -1.71  (7.20) -3.85  (5.94)
At 8-hour post dose -3.09  (6.13) -3.18  (6.26) -4.74  (6.30)
At 10-hour post-dose -2.24  (6.34) -1.74  (6.42) -3.82  (7.26)
At 12-hour post-dose -2.47  (6.59) -2.15  (7.30) -3.15  (6.97)
At 24-hour post dose -5.00  (7.34) -8.47  (5.39) -5.82  (8.18)
4.Secondary Outcome
Title Target Blood Pressure Achievement in Elderly (≥65)
Hide Description Elderly subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg
Time Frame After 2 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects valid for efficacy analysis
Arm/Group Title Nifedipine (Adalat CR, BAYA1040) 40 mg OD Nifedipine (Adalat CR, BAYA1040) 40 mg BID Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Hide Arm/Group Description:
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
Overall Number of Participants Analyzed 5 5 5
Measure Type: Number
Unit of Measure: participants
2 3 3
5.Secondary Outcome
Title Target Blood Pressure Achievement in Non-elderly (<65)
Hide Description Non-elderly subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg
Time Frame After 2 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects valid for efficacy analysis
Arm/Group Title Nifedipine (Adalat CR, BAYA1040) 40 mg OD Nifedipine (Adalat CR, BAYA1040) 40 mg BID Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Hide Arm/Group Description:
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
Overall Number of Participants Analyzed 14 14 14
Measure Type: Number
Unit of Measure: participants
3 10 4
6.Secondary Outcome
Title Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder
Hide Description Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg
Time Frame After 2 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects valid for efficacy analysis
Arm/Group Title Nifedipine (Adalat CR, BAYA1040) 40 mg OD Nifedipine (Adalat CR, BAYA1040) 40 mg BID Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Hide Arm/Group Description:
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
Overall Number of Participants Analyzed 15 15 15
Measure Type: Number
Unit of Measure: participants
0 4 1
7.Secondary Outcome
Title Target Blood Pressure Achievement in All Subjects
Hide Description Subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg. Subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg. Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg.
Time Frame After 2 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects valid for efficacy analysis
Arm/Group Title Nifedipine (Adalat CR, BAYA1040) 40 mg OD Nifedipine (Adalat CR, BAYA1040) 40 mg BID Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Hide Arm/Group Description:
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
Overall Number of Participants Analyzed 34 34 34
Measure Type: Number
Unit of Measure: participants
5 17 8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nifedipine (Adalat CR, BAYA1040) 40 mg OD Nifedipine (Adalat CR, BAYA1040) 40 mg BID Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Hide Arm/Group Description Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
All-Cause Mortality
Nifedipine (Adalat CR, BAYA1040) 40 mg OD Nifedipine (Adalat CR, BAYA1040) 40 mg BID Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nifedipine (Adalat CR, BAYA1040) 40 mg OD Nifedipine (Adalat CR, BAYA1040) 40 mg BID Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/34 (0.00%)   0/34 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nifedipine (Adalat CR, BAYA1040) 40 mg OD Nifedipine (Adalat CR, BAYA1040) 40 mg BID Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/35 (14.29%)   7/34 (20.59%)   5/34 (14.71%) 
Blood and lymphatic system disorders       
Anaemia * 1  2/35 (5.71%)  0/34 (0.00%)  2/34 (5.88%) 
Cardiac disorders       
Atrial fibrillation * 1  1/35 (2.86%)  0/34 (0.00%)  0/34 (0.00%) 
Cardiac murmur * 1  1/35 (2.86%)  0/34 (0.00%)  0/34 (0.00%) 
Carotid arteriosclerosis * 1  0/35 (0.00%)  0/34 (0.00%)  1/34 (2.94%) 
Gastrointestinal disorders       
Stomach discomfort * 1  0/35 (0.00%)  1/34 (2.94%)  0/34 (0.00%) 
Infections and infestations       
Nasopharyngitis * 1  0/35 (0.00%)  2/34 (5.88%)  0/34 (0.00%) 
Investigations       
Blood albumin decreased * 1  1/35 (2.86%)  1/34 (2.94%)  0/34 (0.00%) 
Blood alkaline phosphatase increased * 1  0/35 (0.00%)  1/34 (2.94%)  0/34 (0.00%) 
Blood creatine phosphokinase increased * 1  0/35 (0.00%)  0/34 (0.00%)  1/34 (2.94%) 
Blood triglycerides increased * 1  0/35 (0.00%)  1/34 (2.94%)  0/34 (0.00%) 
Haematocrit decreased * 1  0/35 (0.00%)  1/34 (2.94%)  1/34 (2.94%) 
White blood cell count decreased * 1  0/35 (0.00%)  0/34 (0.00%)  1/34 (2.94%) 
Metabolism and nutrition disorders       
Lipid metabolism disorder * 1  1/35 (2.86%)  1/34 (2.94%)  0/34 (0.00%) 
Nervous system disorders       
Loss of consciousness * 1  0/35 (0.00%)  0/34 (0.00%)  1/34 (2.94%) 
Renal and urinary disorders       
Nocturia * 1  0/35 (0.00%)  0/34 (0.00%)  1/34 (2.94%) 
Skin and subcutaneous tissue disorders       
Swelling face * 1  0/35 (0.00%)  1/34 (2.94%)  0/34 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: BAYER
EMail: clinical-trials-contact@bayerhealthcare.com
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00768560     History of Changes
Other Study ID Numbers: 13012
First Submitted: October 7, 2008
First Posted: October 8, 2008
Results First Submitted: September 28, 2009
Results First Posted: February 2, 2010
Last Update Posted: June 8, 2015