CompletedNCT01193218Updated Jun 17, 2014Results posted

Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus

A Phase 2 interventional study of Placebo (low dose) and Placebo (low dose) in Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim. Completed at 32 sites in Japan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-06-17.

Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 547
Allocation: Randomized
Ages: 20 Years to 80 Years
Sex: All

Study summary

This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period. The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline.

Conditions studied

Diabetes Mellitus, Type 2

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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 547 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Diagnosis of type 2 diabetes mellitus prior to informed consent
Male and female patients on diet and exercise regimen who are:
1. drug-naïve, defined as no antidiabetic drugs for 10 weeks prior to informed consent.
2. pre-treated with one oral antidiabetic drug; the present antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent.
HbA1c at Visit 1a:
1. for patients who are drug naïve: HbA1c >=7.0 to =\<10.0%
2. for patients treated with one oral antidiabetic drug: HbA1c >=6.5 to =\<9.0%
HbA1c of >=7.0% and =\<10% at Visit 2 (start of run-in)

Exclusion criteria

Exclusion criteria:

Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L) after an overnight fast during wash-out/placebo run-in period and confirmed by a second measurement (not on the same day).
Acute coronary syndromes, stroke or transient ischaemic attack within 12 weeks prior to informed consent
Impaired renal function, defined as calculated eGFR \<60 ml/min (MDRD formula) during screening and/or wash-out period and/or run-in phase.
Bariatric surgery within the past 2 years and other gastrointestinal surgeries that induce chronic malabsorption
Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
Treatment with anti-obesity drugs (e.g. sibutramine, mazindol) 12 weeks prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double
Enrollment: 547 participants (actual)

Study arms

Experimental
BI 10773 low dose QD
BI 10773 tablets low dose once a day
Drug: Placebo (mid dose) · Drug: Placebo (high dose) · Drug: BI 10773
Experimental
BI 10773 mid-low dose QD
BI 10773 tablets mid-low dose once a day
Drug: Placebo (high dose) · Drug: Placebo (low dose) · Drug: BI 10773
Experimental
BI 10773 mid-high dose QD
BI 10773 tablets mid-high dose once a day
Drug: BI 10773 · Drug: Placebo (high dose) · Drug: Placebo (low dose) · Drug: Placebo (mid dose)
Experimental
BI 10773 high dose QD
BI 10773 tablets high dose once a day
Drug: Placebo (low dose) · Drug: Placebo (mid dose) · Drug: BI 10773
Placebo comparator
Placebo
Placebo tablets once a day
Drug: Placebo (low dose) · Drug: Placebo (high dose) · Drug: Placebo (mid dose)

Interventions

DrugPlacebo (low dose)
Placebo tablets once a day
DrugPlacebo (low dose)
Placebo tablets once a day
DrugPlacebo (mid dose)
Placebo tablets once a day
DrugPlacebo (high dose)
Placebo tablets once a day
DrugBI 10773
BI 10773 tablets low dose once a day
DrugPlacebo (mid dose)
Placebo tablets once a day
DrugPlacebo (high dose)
Placebo tablets once a day
DrugPlacebo (high dose)
Placebo tablets once a day
DrugBI 10773
BI 10773 tablets mid-high dose once a day
DrugBI 10773
BI 10773 tablets high dose once a day
DrugPlacebo (mid dose)
Placebo tablets once a day
DrugPlacebo (high dose)
Placebo tablets once a day
DrugPlacebo (low dose)
Placebo tablets once a day
DrugPlacebo (low dose)
Placebo tablets once a day
DrugBI 10773
BI 10773 tablets mid-low dose once a day
DrugPlacebo (mid dose)
Placebo tablets once a day

What researchers measure

Primary outcomes

Change From Baseline in HbA1c After 12 Weeks of Treatment.
The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.
Time frame: baseline and 12 weeks

Secondary outcomes

Occurrence of Treat to Target Efficacy Response
Occurrence of treat to target efficacy response, that is an HbA1c of \<7.0% after 12 weeks of treatment
Time frame: baseline and 12 weeks
Change From Baseline in FPG
Change from baseline in FPG after 12 weeks of treatment
Time frame: baseline and 12 weeks

Other outcomes

Confirmed Hypoglycaemic Adverse Events
Number of patients with confirmed hypoglycaemic adverse events
Time frame: between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days

Results

Posted Jun 17, 2014

Participant flow

0-12 Weeks

Participant flow — 0-12 Weeks
Milestone	Placebo/Empa 10mg	Empa 5mg/10mg	Empa 10mg	Empa 25mg	Empa 50mg\10mg
Started	109	110	109	109	110
Completed	100	107	108	106	107
Not completed	9	3	1	3	3
Withdrew: Adverse event	6	1	0	2	2
Withdrew: Protocol violation	0	0	1	1	0
Withdrew: Withdrawal by subject	3	2	0	0	1

12-52 Weeks

Participant flow — 12-52 Weeks
Milestone	Placebo/Empa 10mg	Placebo/Empa 25 mg	Empa 5mg/10mg	Empa 5 mg/25 mg	Empa 10mg	Empa 25mg	Empa 50mg\10mg	Empa 50 mg/25 mg
Started	50	50	54	53	108	106	54	53
Completed	45	50	50	50	104	101	51	49
Not completed	5	0	4	3	4	5	3	4
Withdrew: Adverse event	1	0	1	2	3	3	1	2
Withdrew: Lack of efficacy	0	0	0	0	0	0	1	0
Withdrew: Withdrawal by subject	3	0	3	0	0	2	1	2
Withdrew: Other reason than above	1	0	0	1	1	0	0	0

Outcome measures

PrimaryChange From Baseline in HbA1c After 12 Weeks of Treatment.

The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.

Time frame:: baseline and 12 weeks
Reported as:: Least squares mean · percentage of HbA1c

Change From Baseline in HbA1c After 12 Weeks of Treatment.
percentage of HbA1c	Placebo (12 Week)	Empa 5mg (12 Week)	Empa 10mg (12 Week)	Empa 25mg (12 Week)	Empa 50mg (12 Week)
Change From Baseline in HbA1c After 12 Weeks of Treatment.	0.30 ± 0.09	-0.42 ± 0.09	-0.40 ± 0.09	-0.65 ± 0.09	-0.61 ± 0.09

Statistical analysis

Placebo (12 Week) vs Empa 5mg (12 Week) · ANCOVA · p = <0.0001 (the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.) · Mean difference (final values): -0.72 · 95% CI -0.87 to -0.57'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate
Placebo (12 Week) vs Empa 10mg (12 Week) · ANCOVA · p = <0.0001 (the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.) · Mean difference (final values): -0.70 · 95% CI -0.85 to -0.55'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate
Placebo (12 Week) vs Empa 25mg (12 Week) · ANCOVA · p = <0.0001 (the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.) · Mean difference (final values): -0.95 · 95% CI -1.10 to -0.80'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate
Placebo (12 Week) vs Empa 50mg (12 Week) · ANCOVA · p = <0.0001 (the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.) · Mean difference (final values): -0.91 · 95% CI -1.06 to -0.76'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate

SecondaryOccurrence of Treat to Target Efficacy Response

Occurrence of treat to target efficacy response, that is an HbA1c of \<7.0% after 12 weeks of treatment

Time frame:: baseline and 12 weeks
Reported as:: Number · percentage of participants

Occurrence of Treat to Target Efficacy Response
percentage of participants	Placebo (12 Week)	Empa 5mg (12 Week)	Empa 10mg (12 Week)	Empa 25mg (12 Week)	Empa 50mg (12 Week)
Occurrence of Treat to Target Efficacy Response	2.8 (0.6 to 8.0)	26.2 (18.1 to 35.6)	19.0 (12.0 to 27.9)	32.1 (23.3 to 41.8)	32.7 (24.0 to 42.5)

Statistical analysis

Placebo (12 Week) vs Empa 5mg (12 Week) · Regression, Logistic · p = <0.0001 · Odds ratio (or): 19.367 · 95% CI 5.340 to 70.236The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.
Placebo (12 Week) vs Empa 10mg (12 Week) · Regression, Logistic · p = 0.0003 · Odds ratio (or): 10.889 · 95% CI 2.942 to 40.301The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.
Placebo (12 Week) vs Empa 25mg (12 Week) · Regression, Logistic · p = <0.0001 · Odds ratio (or): 27.624 · 95% CI 7.601 to 99.99The upper limit of confidence interval is actually \>99.99
Placebo (12 Week) vs Empa 50mg (12 Week) · Regression, Logistic · p = <0.0001 · Odds ratio (or): 44.906 · 95% CI 12.120 to 99.99The upper limit of confidence interval is actually \>99.99

SecondaryChange From Baseline in FPG

Change from baseline in FPG after 12 weeks of treatment

Time frame:: baseline and 12 weeks
Reported as:: Least squares mean · mg/dL

Change From Baseline in FPG
mg/dL	Placebo (12 Week)	Empa 5mg (12 Week)	Empa 10mg (12 Week)	Empa 25mg (12 Week)	Empa 50mg (12 Week)
Change From Baseline in FPG	4.06 ± 2.88	-22.65 ± 2.97	-25.28 ± 2.77	-33.70 ± 2.92	-32.54 ± 2.97

Statistical analysis

Placebo (12 Week) vs Empa 5mg (12 Week) · ANCOVA · p = <0.0001 · Mean difference (final values): -26.70 · 95% CI -31.61 to -21.80treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates
Placebo (12 Week) vs Empa 10mg (12 Week) · ANCOVA · p = <0.0001 · Mean difference (final values): -29.34 · 95% CI -34.25 to -24.42treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates
Placebo (12 Week) vs Empa 25mg (12 Week) · ANCOVA · p = <0.0001 · Mean difference (final values): -37.75 · 95% CI -42.66 to -32.84treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates
Placebo (12 Week) vs Empa 50mg (12 Week) · ANCOVA · p = <0.0001 · Mean difference (final values): -36.60 · 95% CI -41.51 to -31.69treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates

Other pre-specifiedConfirmed Hypoglycaemic Adverse Events

Number of patients with confirmed hypoglycaemic adverse events

Time frame:: between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
Reported as:: Number · participants

Confirmed Hypoglycaemic Adverse Events
participants	Placebo (12 Week)	Empa 5mg (12 Week)	Empa 10mg (12 Week)	Empa 25mg (12 Week)	Empa 50mg (12 Week)
Confirmed Hypoglycaemic Adverse Events	0	0	0	1	1

Adverse events

Collected over between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo (12 Week)	—	3/109 (2.8%)	15/109 (13.8%)
Empa 5mg (12 Week)	—	0/110 (0%)	19/110 (17.3%)
Empa 10mg (12 Week)	—	0/109 (0%)	16/109 (14.7%)
Empa 25mg (12 Week)	—	3/109 (2.8%)	26/109 (23.9%)
Empa 50mg (12 Week)	—	1/110 (0.9%)	20/110 (18.2%)
Empa 10mg (Randomized, 52 Week)	—	3/109 (2.8%)	39/109 (35.8%)
Empa 25mg (Randomized, 52 Week)	—	8/109 (7.3%)	49/109 (45%)
Empa 10mg (With at Least One Dose, 52 Week)	—	8/267 (3%)	83/267 (31.1%)
Empa 25mg (With at Least One Dose, 52 Week)	—	15/265 (5.7%)	93/265 (35.1%)

Most frequent serious events

Showing 10 of 29

Most frequent serious events
Event	Placebo (12 Week)	Empa 5mg (12 Week)	Empa 10mg (12 Week)	Empa 25mg (12 Week)	Empa 50mg (12 Week)	Empa 10mg (Randomized, 52 Week)	Empa 25mg (Randomized, 52 Week)	Empa 10mg (With at Least One Dose, 52 Week)	Empa 25mg (With at Least One Dose, 52 Week)
PharyngitisInfections and infestations	0/109	0/110	0/109	1/109	0/110	0/109	1/109	0/267	1/265
Viral infectionInfections and infestations	0/109	0/110	0/109	0/109	0/110	1/109	0/109	1/267	0/265
Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/109	0/110	0/109	0/109	0/110	0/109	1/109	1/267	1/265
Diffuse large B-cell lymphomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/109	0/110	0/109	0/109	0/110	0/109	1/109	0/267	1/265
Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/109	0/110	0/109	1/109	0/110	0/109	1/109	0/267	1/265
Oesophageal carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/109	0/110	0/109	0/109	0/110	0/109	1/109	0/267	1/265
Cerebral infarctionNervous system disorders	0/109	0/110	0/109	1/109	0/110	0/109	1/109	0/267	1/265
GlaucomaEye disorders	1/109	0/110	0/109	0/109	0/110	0/109	0/109	0/267	0/265
Acute myocardial infarctionCardiac disorders	1/109	0/110	0/109	0/109	0/110	0/109	0/109	1/267	0/265
Myocardial infarctionCardiac disorders	1/109	0/110	0/109	0/109	0/110	0/109	0/109	0/267	0/265

Most frequent other events

Most frequent other events
Event	Placebo (12 Week)	Empa 5mg (12 Week)	Empa 10mg (12 Week)	Empa 25mg (12 Week)	Empa 50mg (12 Week)	Empa 10mg (Randomized, 52 Week)	Empa 25mg (Randomized, 52 Week)	Empa 10mg (With at Least One Dose, 52 Week)	Empa 25mg (With at Least One Dose, 52 Week)
NasopharyngitisInfections and infestations	10/109	8/110	9/109	11/109	11/110	30/109	33/109	62/267	63/265
PollakiuriaRenal and urinary disorders	1/109	4/110	1/109	7/109	6/110	1/109	8/109	4/267	10/265
Dental cariesGastrointestinal disorders	0/109	1/110	1/109	1/109	0/110	1/109	7/109	2/267	9/265
PharyngitisInfections and infestations	1/109	0/110	4/109	3/109	2/110	6/109	6/109	11/267	9/265
ConstipationGastrointestinal disorders	3/109	2/110	0/109	4/109	2/110	1/109	6/109	3/267	10/265
Back painMusculoskeletal and connective tissue disorders	0/109	4/110	1/109	0/109	0/110	4/109	4/109	14/267	10/265

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Placebo (12 Week)	Empa 5mg (12 Week)	Empa 10mg (12 Week)	Empa 25mg (12 Week)	Empa 50mg (12 Week)	Total
Mean	58.7 ± 8.7	57.3 ± 11.2	57.9 ± 9.4	57.2 ± 9.7	56.6 ± 10.3	57.5 ± 9.9

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo (12 Week)	Empa 5mg (12 Week)	Empa 10mg (12 Week)	Empa 25mg (12 Week)	Empa 50mg (12 Week)	Total
Female	29	26	32	25	25	137
Male	80	84	77	84	85	410

Study locations

32 sites

1245.38.016 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo, Japan
1245.38.001 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
1245.38.003 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
1245.38.002 Boehringer Ingelheim Investigational Site
Hachioji, Tokyo, Japan
1245.38.010 Boehringer Ingelheim Investigational Site
Hanamaki, Iwate, Japan
1245.38.005 Boehringer Ingelheim Investigational Site
Kamakura, Kanagawa, Japan
1245.38.020 Boehringer Ingelheim Investigational Site
Kanazawa, Ishikawa, Japan
1245.38.013 Boehringer Ingelheim Investigational Site
Kashiwa, Chiba, Japan
1245.38.019 Boehringer Ingelheim Investigational Site
Katsushika-ku, Tokyo, Japan
1245.38.021 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto, Japan
1245.38.024 Boehringer Ingelheim Investigational Site
Matsuyama, Ehime, Japan
1245.38.004 Boehringer Ingelheim Investigational Site
Minato-ku, Tokyo, Japan
1245.38.011 Boehringer Ingelheim Investigational Site
Moriya, Ibaraki, Japan
1245.38.030 Boehringer Ingelheim Investigational Site
Naha, Okinawa, Japan
1245.38.032 Boehringer Ingelheim Investigational Site
Okawa, Fukuoka, Japan
1245.38.031 Boehringer Ingelheim Investigational Site
Okinawa, Okinawa, Japan
1245.38.025 Boehringer Ingelheim Investigational Site
Saga, Saga, Japan
1245.38.014 Boehringer Ingelheim Investigational Site
Saitama, Saitama, Japan
1245.38.006 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1245.38.007 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1245.38.008 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1245.38.009 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1245.38.012 Boehringer Ingelheim Investigational Site
Sasima-gun, Ibaraki, Japan
1245.38.015 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1245.38.018 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1245.38.017 Boehringer Ingelheim Investigational Site
Suginami-ku, Tokyo, Japan
1245.38.022 Boehringer Ingelheim Investigational Site
Suita, Osaka, Japan
1245.38.023 Boehringer Ingelheim Investigational Site
Ube, Yamaguchi, Japan
1245.38.026 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa, Japan
1245.38.027 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa, Japan
1245.38.028 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa, Japan
1245.38.029 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa, Japan

References and documents

Publications

Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034. PubMed 35472672 ↗
Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8. PubMed 28753486 ↗
Kadowaki T, Haneda M, Inagaki N, Terauchi Y, Taniguchi A, Koiwai K, Rattunde H, Woerle HJ, Broedl UC. Efficacy and safety of empagliflozin monotherapy for 52 weeks in Japanese patients with type 2 diabetes: a randomized, double-blind, parallel-group study. Adv Ther. 2015 Apr;32(4):306-18. doi: 10.1007/s12325-015-0198-0. Epub 2015 Apr 7. PubMed 25845768 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01193218
Lead sponsor: Boehringer Ingelheim
Collaborators: Eli Lilly and Company
Responsible party: Sponsor
First posted: Sep 1, 2010
Start date: Sep 2010
Primary completion: Jun 2012
Completion: Jun 2012
Results posted: Jun 17, 2014
Last update: Jun 17, 2014

Study contacts

Boehringer Ingelheim

study chair · Boehringer Ingelheim

View the source record on ClinicalTrials.gov ↗

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Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus

Study summary

Conditions studied

Browse trials for

In context

Diabetes Mellitus

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Other outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Updates

Registry details

Key details

Study contacts

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria