GA YAZ ACNE in China Phase III

• ClinicalTrials.gov Identifier: NCT00818519
• Recruitment Status: Completed
• First Posted: January 7, 2009
• Results First Posted: June 9, 2011
• Last Update Posted: August 25, 2015
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Acne Vulgaris
• Interventions: Drug: EE20/Drospirenone (YAZ, BAY86-5300); Drug: Placebo
• Enrollment: 179

Participant Flow

Recruitment Details	Analyzed: 179 participants randomized, 173 in the FAS (Full Analysis Set): 87 in YAZ, 86 in placebo groups, 143 in the PPS (Per Protocol Set): 74 in YAZ, 69 in placebo groups
Pre-assignment Details	193 participants screened, 14 failed screening: withdrawal of consent (7), inclusion/exclusion criteria not met (6), participant lost/no further information available (1). study drug intake was unknown (3) and 3 participants to whom study drug was never administered (withdrawal of consent or lost to follow-up) were excluded from FAS.

Arm/Group Title	EE20/Drospirenone (YAZ, BAY86-5300)	Placebo
Arm/Group Description	In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).	The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Period Title: Overall Study
Started	89 [1]	90 [2]
Participants Received Treatment	87 [3]	86 [3]
Completed	75	71
Not Completed	14	19
Reason Not Completed
Adverse Event	2	2
Lost to Follow-up	4	6
Protocol Violation	2	1
Pregnancy	0	1
Withdrawal by Subject	4	9
participant recovered completely	1	0
participant will leave for long tme	1	0
[1] 2 excluded from FAS because study drug intake unknown or never administered; [2] 4 excluded from FAS because study drug intake unknown or never administered; [3] = Baseline

Baseline Characteristics

Arm/Group Title		EE20/Drospirenone (YAZ, BAY86-5300)	Placebo	Total
Arm/Group Description		In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).	The participants of the placebo group received inert but identical-appearing, color-matched tablets.	Total of all reporting groups
Overall Number of Baseline Participants		87	86	173
Baseline Analysis Population Description		[Not Specified]
Age, Continuous [1]; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	87 participants	86 participants	173 participants
		24.0 (5.8)	23.4 (5.4)	23.7 (5.6)
		[1] Measure Description: Age of participants was derived from birth date entered onto CRF (Case Report Form)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	87 participants	86 participants	173 participants
	Female	87 100.0%	86 100.0%	173 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the FAS (Full Analysis Set)
Description	Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.
Time Frame	Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	EE20/Drospirenone (YAZ, BAY86-5300)	Placebo
Arm/Group Description:	In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).	The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed	87	86
Mean (Standard Deviation); Unit of Measure: Percent change
	66.79 (31.45)	37.71 (118.73)

2. Primary Outcome

Title	Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the PPS (Per Protocol Set)
Description	Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.
Time Frame	Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline

Outcome Measure Data

Analysis Population Description

PPS

Arm/Group Title	EE20/Drospirenone (YAZ, BAY86-5300)	Placebo
Arm/Group Description:	In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).	The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed	74	69
Mean (Standard Deviation); Unit of Measure: Percent change
	72.63 (27.45)	55.56 (32.50)

3. Secondary Outcome

Title	Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit
Description	ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions
Time Frame	Screening visit

Outcome Measure Data

Analysis Population Description

Full analysis set at screening

Arm/Group Title	EE20/Drospirenone (YAZ, BAY86-5300)	Placebo
Arm/Group Description:	In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).	The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed	87	86
Measure Type: Number; Unit of Measure: Percentage of participants
	0.0	0.0

4. Secondary Outcome

Title	Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1
Description	ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions
Time Frame	Cycle 1 (Day 15±3 days of Treatment Cycle 1)

Outcome Measure Data

Analysis Population Description

FAS, all participants with data for Cycle 1

Arm/Group Title	EE20/Drospirenone (YAZ, BAY86-5300)	Placebo
Arm/Group Description:	In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).	The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed	84	84
Measure Type: Number; Unit of Measure: Percentage of participants
	1.2	0.0

5. Secondary Outcome

Title	Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 3
Description	ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions
Time Frame	Cycle 3 (Day 15±3 days of Treatment Cycle 3)

Outcome Measure Data

Analysis Population Description

FAS, all participants with data for Cycle 3

Arm/Group Title	EE20/Drospirenone (YAZ, BAY86-5300)	Placebo
Arm/Group Description:	In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).	The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed	81	81
Measure Type: Number; Unit of Measure: Percentage of participants
	2.5	4.9

6. Secondary Outcome

Title	Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6
Description	ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions
Time Frame	Cycle 6 (Day 15±3 days of Treatment Cycle 6)

Outcome Measure Data

Analysis Population Description

FAS, all participants with data for Cycle 6

Arm/Group Title	EE20/Drospirenone (YAZ, BAY86-5300)	Placebo
Arm/Group Description:	In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).	The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed	73	71
Measure Type: Number; Unit of Measure: Percentage of participants
	49.3	18.3

7. Secondary Outcome

Title	Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count
Description	Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (lesion count at Baseline - lesion count at Cycle 6)/(lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.
Time Frame	Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline

Outcome Measure Data

Analysis Population Description

FAS (due to missing data number of participants differs from number at Baseline)

Arm/Group Title	EE20/Drospirenone (YAZ, BAY86-5300)	Placebo
Arm/Group Description:	In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).	The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed	75	71
Mean (Standard Deviation); Unit of Measure: Percent change
Inflammatory lesion count	75.49 (28.11)	60.88 (29.92)
Non-inflammatory lesion count	69.27 (33.75)	50.24 (49.93)

8. Secondary Outcome

Title	Percent Change From Cycle 6 to Baseline in Lesion Count of Papules
Description	Acne lesions were counted by the trained designee over the entire face. All papules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (papule count at Baseline - papule count at Cycle 6)/(papule count at Baseline)*100, so that improvement is indicated by a larger percent change.
Time Frame	Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline

Outcome Measure Data

Analysis Population Description

FAS (due to missing data number of participants differs from number at Baseline)

Arm/Group Title	EE20/Drospirenone (YAZ, BAY86-5300)	Placebo
Arm/Group Description:	In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).	The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed	75	71
Mean (Standard Deviation); Unit of Measure: Percent change
	72.36 (31.32)	55.03 (40.19)

9. Secondary Outcome

Title	Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules
Description	Acne lesions were counted by the trained designee over the entire face. All pustules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (pustule count at Baseline - pustule count at Cycle 6)/(pustule count at Baseline)*100, so that improvement is indicated by a larger percent change.
Time Frame	Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline

Outcome Measure Data

Analysis Population Description

FAS (due to missing data number of participants differs from number at Baseline)

Arm/Group Title	EE20/Drospirenone (YAZ, BAY86-5300)	Placebo
Arm/Group Description:	In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).	The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed	64	61
Mean (Standard Deviation); Unit of Measure: Percent change
	79.88 (40.83)	78.15 (34.37)

10. Secondary Outcome

Title	Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules
Description	Acne lesions were counted by the trained designee over the entire face. All nodules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (nodule count at Baseline - nodule count at Cycle 6)/(nodule count at Baseline)*100, so that improvement is indicated by a larger percent change.
Time Frame	Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline

Outcome Measure Data

Analysis Population Description

FAS (due to missing data number of participants differs from number at Baseline)

Arm/Group Title	EE20/Drospirenone (YAZ, BAY86-5300)	Placebo
Arm/Group Description:	In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).	The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed	32	30
Mean (Standard Deviation); Unit of Measure: Percent change
	95.83 (18.45)	95.00 (20.13)

11. Secondary Outcome

Title	Percent Change From Cycle 6 to Baseline in Lesion Count of Open Comedones
Description	Acne lesions were counted by the trained designee over the entire face. All open comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (open comedone count at Baseline -open comedone count at Cycle 6)/(open comedone count at Baseline)*100, so that improvement is indicated by a larger percent change.
Time Frame	Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline

Outcome Measure Data

Analysis Population Description

FAS (due to missing data number of participants differs from number at Baseline)

Arm/Group Title	EE20/Drospirenone (YAZ, BAY86-5300)	Placebo
Arm/Group Description:	In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).	The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed	72	69
Mean (Standard Deviation); Unit of Measure: Percent change
	24.03 (289.46)	38.31 (94.52)

12. Secondary Outcome

Title	Percent Change From Cycle 6 to Baseline in Lesion Count of Closed Comedones
Description	Acne lesions were counted by the trained designee over the entire face. All closed comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (closed comedone count at Baseline - closed comedone count at Cycle 6)/(closed comedone count at Baseline)*100, so that improvement is indicated by a larger percent change.
Time Frame	Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline

Outcome Measure Data

Analysis Population Description

FAS (due to missing data number of participants differs from number at Baseline)

Arm/Group Title	EE20/Drospirenone (YAZ, BAY86-5300)	Placebo
Arm/Group Description:	In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).	The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed	75	70
Mean (Standard Deviation); Unit of Measure: Percent change
	69.52 (42.24)	48.73 (61.16)

13. Secondary Outcome

Title	Percentage of Participants Classified as “Improved” According to the Investigator’s Overall Improvement Rating and on the Participant’s Overall Self-Assessment Rating
Description	The proportion of participants rated as “improved” comprises those with complete remission, excellent, marked, or moderate improvement according to the Investigator’s Overall Improvement Rating and those with excellent, good, or fair improvement the Participant’s Overall Self-Assessment Rating. No improvement or deterioration (worsening of disease signs and symptoms compared to Baseline in the view of investigator/subject) comprise "not improved" status.
Time Frame	At Cycle 6 (Day 15±3 days of Treatment Cycle 6, 28 days per cycle)

Outcome Measure Data

Analysis Population Description

FAS (due to missing data number of participants differs from number at Baseline)

Arm/Group Title	EE20/Drospirenone (YAZ, BAY86-5300)	Placebo
Arm/Group Description:	In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).	The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Overall Number of Participants Analyzed	79	73
Measure Type: Number; Unit of Measure: Percentage of participants
Investigator	93.7	78.1
Participant	94.9	84.9

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	EE20/Drospirenone (YAZ, BAY86-5300)	Placebo
Arm/Group Description	In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).	The participants of the placebo group received inert but identical-appearing, color-matched tablets.
All-Cause Mortality
	EE20/Drospirenone (YAZ, BAY86-5300)	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	EE20/Drospirenone (YAZ, BAY86-5300)	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/87 (0.00%)	0/86 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	EE20/Drospirenone (YAZ, BAY86-5300)	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	34/87 (39.08%)	19/86 (22.09%)
Gastrointestinal disorders
Abdominal pain * 1	2/87 (2.30%)	0/86 (0.00%)
Abdominal pain upper * 1	1/87 (1.15%)	0/86 (0.00%)
Diarrhoea * 1	1/87 (1.15%)	0/86 (0.00%)
Nausea * 1	1/87 (1.15%)	0/86 (0.00%)
Toothache * 1	1/87 (1.15%)	0/86 (0.00%)
Vomiting * 1	1/87 (1.15%)	0/86 (0.00%)
General disorders
Pyrexia * 1	1/87 (1.15%)	0/86 (0.00%)
Infections and infestations
Cervicitis * 1	1/87 (1.15%)	0/86 (0.00%)
Nasopharyngitis * 1	4/87 (4.60%)	2/86 (2.33%)
Pelvic inflammatory disease * 1	0/87 (0.00%)	1/86 (1.16%)
Pneumonia * 1	0/87 (0.00%)	1/86 (1.16%)
Papilloma viral infection * 1	0/87 (0.00%)	1/86 (1.16%)
Investigations
Blood cholesterol increased * 1	3/87 (3.45%)	1/86 (1.16%)
Blood potassium decreased * 1	0/87 (0.00%)	1/86 (1.16%)
Blood triglycerides increased * 1	1/87 (1.15%)	0/86 (0.00%)
Glycosylated haemoglobin increased * 1	1/87 (1.15%)	0/86 (0.00%)
Red blood cells urine positive * 1	0/87 (0.00%)	2/86 (2.33%)
White blood cell count decreased * 1	0/87 (0.00%)	1/86 (1.16%)
White blood cells urine positive * 1	1/87 (1.15%)	2/86 (2.33%)
Metabolism and nutrition disorders
Hyperlipidaemia * 1	1/87 (1.15%)	0/86 (0.00%)
Nervous system disorders
Dizziness * 1	0/87 (0.00%)	1/86 (1.16%)
Reproductive system and breast disorders
Breast mass * 1	2/87 (2.30%)	2/86 (2.33%)
Breast pain * 1	1/87 (1.15%)	2/86 (2.33%)
Cervical dysplasia * 1	0/87 (0.00%)	2/86 (2.33%)
Fibrocystic breast disease * 1	1/87 (1.15%)	0/86 (0.00%)
Hypomenorrhoea * 1	1/87 (1.15%)	0/86 (0.00%)
Menorrhagia * 1	7/87 (8.05%)	0/86 (0.00%)
Menstrual disorder * 1	1/87 (1.15%)	0/86 (0.00%)
Menstruation delayed * 1	0/87 (0.00%)	1/86 (1.16%)
Metrorrhagia * 1	7/87 (8.05%)	0/86 (0.00%)
Oligomenorrhoea * 1	1/87 (1.15%)	0/86 (0.00%)
Vaginal haemorrhage * 1	1/87 (1.15%)	0/86 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough * 1	1/87 (1.15%)	0/86 (0.00%)
Skin and subcutaneous tissue disorders
Acne * 1	0/87 (0.00%)	3/86 (3.49%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 13.0

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Therapeutic Area Head
• Organization: BAYER
• EMail: clinical-trials-contact@bayerhealthcare.com

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00818519 History of Changes
• Other Study ID Numbers: 91772; 311963 ( Other Identifier: Company internal ); 2014-004612-10 ( EudraCT Number )
• First Submitted: January 6, 2009
• First Posted: January 7, 2009
• Results First Submitted: April 6, 2011
• Results First Posted: June 9, 2011
• Last Update Posted: August 25, 2015