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INNOVATION Study - Telmisartan (Micardis) in Incipient Diabetic Nephropathy

Primary Purpose

Diabetic Nephropathies

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Telmisartan capsule 40 mg
Placebo
Telmisartan capsule 80 mg
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathies

Eligibility Criteria

30 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Outpatients who are able to visit the study site throughout the run-in period Aged 30 and 74 years Type II diabetes mellitus Patients with urinary albumin to creatinine ratios within the following ranges at 2 measuring points during the run-in period 1) the first-morning voided urine, iin the range of 100 to 300 mg/g Creatinine 2) < 100 mg/g Creatinine at either point of Visit 2 or 3, but in the range of 100 to 300 mg/g Creatinine at follow-up Serum creatinine level of < 1.5 mg/dL in male and < 1.3 mg/dL in female Normotensive or hypertensive patients Patients taking AT1 antagonists or ACE inhibitors at screening, but are able to stop those drugs during the study Patients who are able to provide written informed consent in accordance with the Good Clinical Practice (GCP) and other relevant laws such as the Pharmaceutical Affairs Law Exclusion Criteria: Age of onset of type 2 diabetes is < 30 years Type I diabetes Urinary albumin to creatinine ratio of > 300 mg/g Creatinine HbA1c 9% Seated SBP 180 mmHg or DBP 110 mmHg Findings suggesting a renal disease other than diabetic nephropathy; such as post renal transplantation, history of non-diabetic renal disease, marked haematuria, complication of urinary tract infection Cardiovascular diseases: Patients with unstable angina, myocardial infarction, CABG, PTCA within 6 months before CHF with NYHA III-IV TIA within 6 months Stroke within 6 months AV block (grade II-III) or AF Serious arrhythmia Known or suspected secondary HT History of angioedema during administration of ARB/ACE-i Hypersensitivity History of sudden exacerbation of renal function due to ARB/ACE-i Markedly poor bile secretion Hepatic dysfunction: SGPT (ALT) or SGOT (AST) 100 IU/L Serum potassium level < 3.5 mEq/L or 5.1 mEq/L Unable to discontinue ARB/ACE-i Require prolonged administration of any medications affecting blood pressure, except diuretics, or blockers, and CCB Untreated sodium depletion Pre-menopausal females who meet any one of the following: Pregnant or possibly pregnant Breast-feeding Hope to be pregnant during the study period Even when a patient is confirmed not to meet the above criteria at the start of the study, a female patient who has the potential to be pregnant during the study is to undergo pregnancy tests. If the result turns positive, the study medication should be discontinued. Malignant tumour or other diseases requiring oral or injection immunosuppressants Non-compliance History of drug or alcohol abuse Participated in other clinical studies within 3 months Any other conditions investigators judged as ineligible

Sites / Locations

  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
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  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
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  • Boehringer Ingelheim Investigational Site
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  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
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  • Boehringer Ingelheim Investigational Site
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Outcomes

Primary Outcome Measures

Non-transition to overt nephropathy

Secondary Outcome Measures

Change in renal parameters Composite endpoint

Full Information

First Posted
September 9, 2005
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00153088
Brief Title
INNOVATION Study - Telmisartan (Micardis) in Incipient Diabetic Nephropathy
Official Title
A Randomised, Double-blind, Placebo-controlled, Multicenter Trial to Investigate the Preventive Effect of BIBR277 (Telmisartan) in Diabetic Nephropathy on Transition From Incipient to Overt Nephropathy - Incipient to Overt : Angiotensin 2 Receptor Blocker, Telmisartan, Investigation on Type 2 Diabetic Nephropathy (INNOVATION Study -
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The aim of this study is to compare the preventive effect of Telmisartan(Micardis) versus placebo control on the transition to overt nephropathy in patients with diabetic nephropathy manifesting microalbuminuria associated with type II diabetes, and to evaluate the efficacy and safety of Telmisart (Micardis, Gliosartan, Kinzal, Kinzalmono, Predxal, Pritor, Samertan, Telmisartan) for diabetic nephropathy patients.
Detailed Description
A prospective, randomised, double-blind, multicentric and comparative study to investigate, on a long-term basis, the preventive effect on the transition to overt nephropathy and the safety of Telmisartan (Micardis) against placebo in patients with diabetic nephropathy, manifesting microalbuminuria associated with type II diabetes. Study Hypothesis: The hypothesis is that Telmisartan (Micardis) at 40 mg or 80 mg versus placebo control in patients with concurrent type II diabetic mellitus or diabetic nephropathy demonstrating microalbuminuria, has the preventive effect on transition from incipient to overt nephropathy. Comparison(s): The primary endpoint is defined as the transition from incipient to overt nephropathy, and the non-transition curve will be demonstrated based on the Kaplan-Meier method. The evaluation criteria for the point to transition to overt nephropathy is defined as urinary albumin to creatinine ratios at consecutive 2 measuring points increasing over 300 mg/g-Creatinine and excess 30% increase comparing with the baseline value. The curve of non-transition will be compared with Logrank test. Those in BIBR277 groups are sequentially compared with that in the placebo group by the closed testing procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
527 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Telmisartan capsule 40 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Telmisartan capsule 80 mg
Primary Outcome Measure Information:
Title
Non-transition to overt nephropathy
Secondary Outcome Measure Information:
Title
Change in renal parameters Composite endpoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatients who are able to visit the study site throughout the run-in period Aged 30 and 74 years Type II diabetes mellitus Patients with urinary albumin to creatinine ratios within the following ranges at 2 measuring points during the run-in period 1) the first-morning voided urine, iin the range of 100 to 300 mg/g Creatinine 2) < 100 mg/g Creatinine at either point of Visit 2 or 3, but in the range of 100 to 300 mg/g Creatinine at follow-up Serum creatinine level of < 1.5 mg/dL in male and < 1.3 mg/dL in female Normotensive or hypertensive patients Patients taking AT1 antagonists or ACE inhibitors at screening, but are able to stop those drugs during the study Patients who are able to provide written informed consent in accordance with the Good Clinical Practice (GCP) and other relevant laws such as the Pharmaceutical Affairs Law Exclusion Criteria: Age of onset of type 2 diabetes is < 30 years Type I diabetes Urinary albumin to creatinine ratio of > 300 mg/g Creatinine HbA1c 9% Seated SBP 180 mmHg or DBP 110 mmHg Findings suggesting a renal disease other than diabetic nephropathy; such as post renal transplantation, history of non-diabetic renal disease, marked haematuria, complication of urinary tract infection Cardiovascular diseases: Patients with unstable angina, myocardial infarction, CABG, PTCA within 6 months before CHF with NYHA III-IV TIA within 6 months Stroke within 6 months AV block (grade II-III) or AF Serious arrhythmia Known or suspected secondary HT History of angioedema during administration of ARB/ACE-i Hypersensitivity History of sudden exacerbation of renal function due to ARB/ACE-i Markedly poor bile secretion Hepatic dysfunction: SGPT (ALT) or SGOT (AST) 100 IU/L Serum potassium level < 3.5 mEq/L or 5.1 mEq/L Unable to discontinue ARB/ACE-i Require prolonged administration of any medications affecting blood pressure, except diuretics, or blockers, and CCB Untreated sodium depletion Pre-menopausal females who meet any one of the following: Pregnant or possibly pregnant Breast-feeding Hope to be pregnant during the study period Even when a patient is confirmed not to meet the above criteria at the start of the study, a female patient who has the potential to be pregnant during the study is to undergo pregnancy tests. If the result turns positive, the study medication should be discontinued. Malignant tumour or other diseases requiring oral or injection immunosuppressants Non-compliance History of drug or alcohol abuse Participated in other clinical studies within 3 months Any other conditions investigators judged as ineligible
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Nippon Boehringer Ingelheim Co., Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Boehringer Ingelheim Investigational Site
City
Adachi-ku, Tokyo
ZIP/Postal Code
121-0813
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Amagasaki, Hyogo
ZIP/Postal Code
661-0002
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Arakawa-ku, Tokyo
ZIP/Postal Code
116-0011
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Asaguchi-gun, Okayama
ZIP/Postal Code
719-0113
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Asahi, Chiba
ZIP/Postal Code
289-2511
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Asahikawa, Hokkaido
ZIP/Postal Code
070-8610
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Asahikwa, Hokkaido
ZIP/Postal Code
070-8530
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Atami, Shizuoka
ZIP/Postal Code
413-0012
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Atsugi,Kanagawa
ZIP/Postal Code
243-0013
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Chikugo, Fukuoka
ZIP/Postal Code
833-0041
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Chisagata-gun, Nagano
ZIP/Postal Code
386-0396
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Chisagata-gun, Nagano
ZIP/Postal Code
386-0493
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Chitose, Hokkaido
ZIP/Postal Code
066-0081
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Chiyoda, Tokyo
ZIP/Postal Code
100-0005
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Chiyoda-ku, Tokyo
ZIP/Postal Code
101-8326
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Chiyoda-ku, Tokyo
ZIP/Postal Code
102-8798
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Ebina, Kanagawa
ZIP/Postal Code
243-0432
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Fujisawa, Kanagawa
ZIP/Postal Code
252-0802
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Fukuoka, Fukuoka
ZIP/Postal Code
812-0053
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Fukuoka, Fukuoka
ZIP/Postal Code
814-0163
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Fukuoka, Fukuoka
ZIP/Postal Code
814-0171
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Fukuyama, Hiroshima
ZIP/Postal Code
720-0825
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Funabashi, Chiba
ZIP/Postal Code
247-0805
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Furukawa, Miyagi
ZIP/Postal Code
989-6183
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Gifu, Gifu
ZIP/Postal Code
501-1198
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Gobo, Wakayama
ZIP/Postal Code
644-0011
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Hachioji, Tokyo
ZIP/Postal Code
193-0998
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Hakodate, Hokkaido
ZIP/Postal Code
040-8585
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Hanamaki, Iwate
ZIP/Postal Code
025-0075
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Hannan, Osaka
ZIP/Postal Code
599-0202
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Hashima-gun, Gifu
ZIP/Postal Code
501-6062
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Hatsukaichi, Hiroshima
ZIP/Postal Code
738-0033
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Hirakata, Osaka
ZIP/Postal Code
573-1196
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Hitachiota, Ibaragi
ZIP/Postal Code
313-0014
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Ichinomiya, Aichi
ZIP/Postal Code
491-8551
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Iida, Nagano
ZIP/Postal Code
395-8558
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Ikeda, Osaka
ZIP/Postal Code
563-8510
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Inashiki-gun, Ibaragi
ZIP/Postal Code
300-0395
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Isehara, Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Isezaki, Gunma
ZIP/Postal Code
372-0001
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Itami, Hyogo
ZIP/Postal Code
664-8533
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Izumisano, Osaka
ZIP/Postal Code
598-0048
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kamakura, Kanagawa
ZIP/Postal Code
247-0055
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kamakura, Kanagawa
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kamogawa, Chiba
ZIP/Postal Code
296-8602
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Katsushika-ku, Tokyo
ZIP/Postal Code
125-0041
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kawagoe, Saitama
ZIP/Postal Code
350-0042
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kawaguchi, Saitama
ZIP/Postal Code
332-8558
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kawasaki, Kanagawa
ZIP/Postal Code
210-0013
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kawasaki, Kanagawa
ZIP/Postal Code
210-0924
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kawasaki, Kanagawa
ZIP/Postal Code
211-0035
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kawasaki, Kanagawa
ZIP/Postal Code
211-8510
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kawasaki, Kanagawa
ZIP/Postal Code
215-0022
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kawasaki, Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kisarazu, Chiba
ZIP/Postal Code
292-8535
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kita-katushika-gun, Saitama
ZIP/Postal Code
349-1105
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kita-ku, Tokyo
ZIP/Postal Code
114-0004
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kitami, Hokkaido
ZIP/Postal Code
090-0040
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kobe, Hyogo
ZIP/Postal Code
651-1242
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kobe, Hyogo
ZIP/Postal Code
654-0047
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kochi, Kochi
ZIP/Postal Code
780-8562
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kochi, Kochi
ZIP/Postal Code
781-0011
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kodaira, Tokyo
ZIP/Postal Code
187-0003
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kodaira, Tokyo
ZIP/Postal Code
187-8510
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Komaki, Aichi
ZIP/Postal Code
485-8520
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Komatsushima, Tokushima
ZIP/Postal Code
773-8502
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Koriyama, Fukushima
ZIP/Postal Code
963-8563
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Koriyama, Fukushima
ZIP/Postal Code
963-8585
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Koriyama,Fukushima
ZIP/Postal Code
963-8022
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kounan, Aichi
ZIP/Postal Code
483-8702
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kumagaya, Saitama
ZIP/Postal Code
360-0854
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kurashiki, Okayama
ZIP/Postal Code
701-0192
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kurashiki, Okayama
ZIP/Postal Code
710-0826
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kyoto, Kyoto
ZIP/Postal Code
615-8087
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Matsuyama, Ehime
ZIP/Postal Code
790-0024
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Matsuyama, Ehime
ZIP/Postal Code
791-8026
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Minato-ku, Tokyo
ZIP/Postal Code
106-0045
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Minato-ku, Tokyo
ZIP/Postal Code
108-0073
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Minato-ku, Tokyo
ZIP/Postal Code
192-0363
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Musashino, Tokyo
ZIP/Postal Code
180-8610
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Nagoya, Aichi
ZIP/Postal Code
451-8511
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Nagoya, Aichi
ZIP/Postal Code
454-0933
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Nagoya, Aichi
ZIP/Postal Code
455-8530
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Nagoya, Aichi
ZIP/Postal Code
462-0802
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Nagoya, Aichi
ZIP/Postal Code
462-0825
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Nagoya, Aichi
ZIP/Postal Code
465-0025
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Nagoya, Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Nakano-ku, Tokyo
ZIP/Postal Code
164-0011
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Nangoku, Kochi
ZIP/Postal Code
783-8505
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Nishinomiya, Hyogo
ZIP/Postal Code
662-0971
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Nishinomiya, Hyogo
ZIP/Postal Code
663-8211
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Nishinomiya, Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Noda, Chiba
ZIP/Postal Code
278-8501
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Nomi, Ishikawa
ZIP/Postal Code
923-1226
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Obihiro, Hokkaido
ZIP/Postal Code
080-0848
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Odawara, Kanagawa
ZIP/Postal Code
250-0011
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Oita, Oita
ZIP/Postal Code
870-0039
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Okawa, Fukuoka
ZIP/Postal Code
831-0016
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Okayama, Okayama
ZIP/Postal Code
700-8505
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Okayama, Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Okayama, Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Osaka, Osaka
ZIP/Postal Code
543-0002
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Osaka, Osaka
ZIP/Postal Code
543-0035
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Osaka, Osaka
ZIP/Postal Code
553-0003
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Osaka-sayama, Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Osaka
ZIP/Postal Code
545-0021
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Otaru, Hokkaido
ZIP/Postal Code
047-8550
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Oyama, Tochigi
ZIP/Postal Code
323-0022
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sagamihara, Kanagawa
ZIP/Postal Code
228-8555
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sagamihara, Kanagawa
ZIP/Postal Code
229-1125
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sakai, Osaka
ZIP/Postal Code
590-0132
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sakai, Osaka
ZIP/Postal Code
591-8025
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
ZIP/Postal Code
001-0023
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
ZIP/Postal Code
001-0024
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
ZIP/Postal Code
003-0023
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
ZIP/Postal Code
003-8585
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
ZIP/Postal Code
004-0053
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
ZIP/Postal Code
006-0811
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
ZIP/Postal Code
060-0062
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
ZIP/Postal Code
062-0007
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
ZIP/Postal Code
062-0931
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
ZIP/Postal Code
064-0953
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
ZIP/Postal Code
064-8622
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
ZIP/Postal Code
065-0027
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sendai, Miyagi
ZIP/Postal Code
980-0021
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sendai, Miyagi
ZIP/Postal Code
981-8501
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Setagaya-ku, Tokyo
ZIP/Postal Code
158-8531
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Seto, Aichi
ZIP/Postal Code
489-8642
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Shibetsu, Hokkaido
ZIP/Postal Code
095-0014
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Shibuya-ku, Tokyo
ZIP/Postal Code
150-0013
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Shibuya-ku, Tokyo
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Shinagawa, Tokyo
ZIP/Postal Code
140-8522
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Shinjuku-ku, Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Shinjyuku-ku, Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Shiojiri, Nagano
ZIP/Postal Code
399-0702
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sunagawa, Hokkaido
ZIP/Postal Code
073-0196
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Takamatsu, Kagawa
ZIP/Postal Code
760-0018
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Takarazuka, Hyogo
ZIP/Postal Code
665-0827
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Takasaki, Gunma
ZIP/Postal Code
370-0069
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Takatsuki, Osaka
ZIP/Postal Code
569-1096
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Tama, Tokyo
ZIP/Postal Code
206-0025
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Toride, Ibaraki
ZIP/Postal Code
302-0022
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Tosu, Saga
ZIP/Postal Code
841-0061
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Toyohashi, Aichi
ZIP/Postal Code
441-8021
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Toyohashi, Aichi
ZIP/Postal Code
441-8570
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Toyota, Aichi
ZIP/Postal Code
471-8513
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Tsuchiura, Ibaraki
ZIP/Postal Code
300-0047
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Tsuchiura,Ibaraki
ZIP/Postal Code
300-0053
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Tsukuba, Ibaragi
ZIP/Postal Code
305-0812
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Uji, Kyoto
ZIP/Postal Code
611-0013
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Ushiku, Ibaraki
ZIP/Postal Code
300-1296
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Uwajima, Ehime
ZIP/Postal Code
798-8510
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Yokohama, Kanagawa
ZIP/Postal Code
222-0033
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Yokohama, Kanagawa
ZIP/Postal Code
227-0046
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Yokohama, Kanagawa
ZIP/Postal Code
227-0062
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Yokohama, Kanagawa
ZIP/Postal Code
235-0045
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Yokohama, Kanagawa
ZIP/Postal Code
236-0016
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Yokohama, Kanagawa
ZIP/Postal Code
240-8585
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Yokohama, Kanagawa
ZIP/Postal Code
247-0006
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.413_U06-3287-01.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.413_literature.pdf
Description
Related Info

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INNOVATION Study - Telmisartan (Micardis) in Incipient Diabetic Nephropathy

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