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Diabetic NephropathiesPhase 4NCT00153088

INNOVATION Study - Telmisartan (Micardis) in Incipient Diabetic Nephropathy

A Phase 4 study testing Telmisartan capsule 40 mg and Telmisartan capsule 80 mg in people with Diabetic Nephropathies, run by Boehringer Ingelheim at 160 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 74 years
Conditions the study is for
Diabetic Nephropathies
What is being tested?
Telmisartan capsule 40 mg and Telmisartan capsule 80 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
527 participants
Where
160 sitesJapan
Study dates
Jan 2003to Nov 2005
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 33Show fewer
  • 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

Trial locations and contacts

160 sites in 1 country.

160 sites in 1 country

Japan160 sites

  • Boehringer Ingelheim Investigational Site

    Adachi-ku, Tokyo, 121-0813

  • Boehringer Ingelheim Investigational Site

    Amagasaki, Hyogo, 661-0002

  • Boehringer Ingelheim Investigational Site

    Arakawa-ku, Tokyo, 116-0011

  • Boehringer Ingelheim Investigational Site

    Asaguchi-gun, Okayama, 719-0113

  • Boehringer Ingelheim Investigational Site

    Asahi, Chiba, 289-2511

  • Boehringer Ingelheim Investigational Site

    Asahikawa, Hokkaido, 070-8610

  • Boehringer Ingelheim Investigational Site

    Asahikwa, Hokkaido, 070-8530

  • Boehringer Ingelheim Investigational Site

    Atami, Shizuoka, 413-0012

  • Boehringer Ingelheim Investigational Site

    Atsugi,Kanagawa, 243-0013

  • Boehringer Ingelheim Investigational Site

    Chikugo, Fukuoka, 833-0041

  • Boehringer Ingelheim Investigational Site

    Chisagata-gun, Nagano, 386-0396

  • Boehringer Ingelheim Investigational Site

    Chisagata-gun, Nagano, 386-0493

  • Boehringer Ingelheim Investigational Site

    Chitose, Hokkaido, 066-0081

  • Boehringer Ingelheim Investigational Site

    Chiyoda-ku, Tokyo, 101-8326

  • Boehringer Ingelheim Investigational Site

    Chiyoda-ku, Tokyo, 102-8798

  • Boehringer Ingelheim Investigational Site

    Chiyoda, Tokyo, 100-0005

  • Boehringer Ingelheim Investigational Site

    Ebina, Kanagawa, 243-0432

  • Boehringer Ingelheim Investigational Site

    Fujisawa, Kanagawa, 252-0802

  • Boehringer Ingelheim Investigational Site

    Fukuoka, Fukuoka, 812-0053

  • Boehringer Ingelheim Investigational Site

    Fukuoka, Fukuoka, 814-0163

  • Boehringer Ingelheim Investigational Site

    Fukuoka, Fukuoka, 814-0171

  • Boehringer Ingelheim Investigational Site

    Fukuyama, Hiroshima, 720-0825

  • Boehringer Ingelheim Investigational Site

    Funabashi, Chiba, 247-0805

  • Boehringer Ingelheim Investigational Site

    Furukawa, Miyagi, 989-6183

  • Boehringer Ingelheim Investigational Site

    Gifu, Gifu, 501-1198

  • Boehringer Ingelheim Investigational Site

    Gobo, Wakayama, 644-0011

  • Boehringer Ingelheim Investigational Site

    Hachioji, Tokyo, 193-0998

  • Boehringer Ingelheim Investigational Site

    Hakodate, Hokkaido, 040-8585

  • Boehringer Ingelheim Investigational Site

    Hanamaki, Iwate, 025-0075

  • Boehringer Ingelheim Investigational Site

    Hannan, Osaka, 599-0202

  • Boehringer Ingelheim Investigational Site

    Hashima-gun, Gifu, 501-6062

  • Boehringer Ingelheim Investigational Site

    Hatsukaichi, Hiroshima, 738-0033

  • Boehringer Ingelheim Investigational Site

    Hirakata, Osaka, 573-1196

  • Boehringer Ingelheim Investigational Site

    Hitachiota, Ibaragi, 313-0014

  • Boehringer Ingelheim Investigational Site

    Ichinomiya, Aichi, 491-8551

  • Boehringer Ingelheim Investigational Site

    Iida, Nagano, 395-8558

  • Boehringer Ingelheim Investigational Site

    Ikeda, Osaka, 563-8510

  • Boehringer Ingelheim Investigational Site

    Inashiki-gun, Ibaragi, 300-0395

  • Boehringer Ingelheim Investigational Site

    Isehara, Kanagawa, 259-1193

  • Boehringer Ingelheim Investigational Site

    Isezaki, Gunma, 372-0001

  • Boehringer Ingelheim Investigational Site

    Itami, Hyogo, 664-8533

  • Boehringer Ingelheim Investigational Site

    Izumisano, Osaka, 598-0048

  • Boehringer Ingelheim Investigational Site

    Kamakura, Kanagawa, 247-0055

  • Boehringer Ingelheim Investigational Site

    Kamakura, Kanagawa, 247-0056

  • Boehringer Ingelheim Investigational Site

    Kamogawa, Chiba, 296-8602

  • Boehringer Ingelheim Investigational Site

    Katsushika-ku, Tokyo, 125-0041

  • Boehringer Ingelheim Investigational Site

    Kawagoe, Saitama, 350-0042

  • Boehringer Ingelheim Investigational Site

    Kawaguchi, Saitama, 332-8558

  • Boehringer Ingelheim Investigational Site

    Kawasaki, Kanagawa, 210-0013

  • Boehringer Ingelheim Investigational Site

    Kawasaki, Kanagawa, 210-0924

  • Boehringer Ingelheim Investigational Site

    Kawasaki, Kanagawa, 211-0035

  • Boehringer Ingelheim Investigational Site

    Kawasaki, Kanagawa, 211-8510

  • Boehringer Ingelheim Investigational Site

    Kawasaki, Kanagawa, 215-0022

  • Boehringer Ingelheim Investigational Site

    Kawasaki, Kanagawa, 216-8511

  • Boehringer Ingelheim Investigational Site

    Kisarazu, Chiba, 292-8535

  • Boehringer Ingelheim Investigational Site

    Kita-katushika-gun, Saitama, 349-1105

  • Boehringer Ingelheim Investigational Site

    Kita-ku, Tokyo, 114-0004

  • Boehringer Ingelheim Investigational Site

    Kitami, Hokkaido, 090-0040

  • Boehringer Ingelheim Investigational Site

    Kobe, Hyogo, 651-1242

  • Boehringer Ingelheim Investigational Site

    Kobe, Hyogo, 654-0047

  • Boehringer Ingelheim Investigational Site

    Kochi, Kochi, 780-8562

  • Boehringer Ingelheim Investigational Site

    Kochi, Kochi, 781-0011

  • Boehringer Ingelheim Investigational Site

    Kodaira, Tokyo, 187-0003

  • Boehringer Ingelheim Investigational Site

    Kodaira, Tokyo, 187-8510

  • Boehringer Ingelheim Investigational Site

    Komaki, Aichi, 485-8520

  • Boehringer Ingelheim Investigational Site

    Komatsushima, Tokushima, 773-8502

  • Boehringer Ingelheim Investigational Site

    Koriyama, Fukushima, 963-8563

  • Boehringer Ingelheim Investigational Site

    Koriyama, Fukushima, 963-8585

  • Boehringer Ingelheim Investigational Site

    Koriyama,Fukushima, 963-8022

  • Boehringer Ingelheim Investigational Site

    Kounan, Aichi, 483-8702

  • Boehringer Ingelheim Investigational Site

    Kumagaya, Saitama, 360-0854

  • Boehringer Ingelheim Investigational Site

    Kurashiki, Okayama, 701-0192

  • Boehringer Ingelheim Investigational Site

    Kurashiki, Okayama, 710-0826

  • Boehringer Ingelheim Investigational Site

    Kyoto, Kyoto, 615-8087

  • Boehringer Ingelheim Investigational Site

    Matsuyama, Ehime, 790-0024

  • Boehringer Ingelheim Investigational Site

    Matsuyama, Ehime, 791-8026

  • Boehringer Ingelheim Investigational Site

    Minato-ku, Tokyo, 106-0045

  • Boehringer Ingelheim Investigational Site

    Minato-ku, Tokyo, 108-0073

  • Boehringer Ingelheim Investigational Site

    Minato-ku, Tokyo, 192-0363

  • Boehringer Ingelheim Investigational Site

    Musashino, Tokyo, 180-8610

  • Boehringer Ingelheim Investigational Site

    Nagoya, Aichi, 451-8511

  • Boehringer Ingelheim Investigational Site

    Nagoya, Aichi, 454-0933

  • Boehringer Ingelheim Investigational Site

    Nagoya, Aichi, 455-8530

  • Boehringer Ingelheim Investigational Site

    Nagoya, Aichi, 462-0802

  • Boehringer Ingelheim Investigational Site

    Nagoya, Aichi, 462-0825

  • Boehringer Ingelheim Investigational Site

    Nagoya, Aichi, 465-0025

  • Boehringer Ingelheim Investigational Site

    Nagoya, Aichi, 467-8602

  • Boehringer Ingelheim Investigational Site

    Nakano-ku, Tokyo, 164-0011

  • Boehringer Ingelheim Investigational Site

    Nangoku, Kochi, 783-8505

  • Boehringer Ingelheim Investigational Site

    Nishinomiya, Hyogo, 662-0971

  • Boehringer Ingelheim Investigational Site

    Nishinomiya, Hyogo, 663-8211

  • Boehringer Ingelheim Investigational Site

    Nishinomiya, Hyogo, 663-8501

  • Boehringer Ingelheim Investigational Site

    Noda, Chiba, 278-8501

  • Boehringer Ingelheim Investigational Site

    Nomi, Ishikawa, 923-1226

  • Boehringer Ingelheim Investigational Site

    Obihiro, Hokkaido, 080-0848

  • Boehringer Ingelheim Investigational Site

    Odawara, Kanagawa, 250-0011

  • Boehringer Ingelheim Investigational Site

    Oita, Oita, 870-0039

  • Boehringer Ingelheim Investigational Site

    Okawa, Fukuoka, 831-0016

  • Boehringer Ingelheim Investigational Site

    Okayama, Okayama, 700-8505

  • Boehringer Ingelheim Investigational Site

    Okayama, Okayama, 700-8558

  • Boehringer Ingelheim Investigational Site

    Okayama, Okayama, 701-1192

  • Boehringer Ingelheim Investigational Site

    Osaka, 545-0021

  • Boehringer Ingelheim Investigational Site

    Osaka-sayama, Osaka, 589-8511

  • Boehringer Ingelheim Investigational Site

    Osaka, Osaka, 543-0002

  • Boehringer Ingelheim Investigational Site

    Osaka, Osaka, 543-0035

  • Boehringer Ingelheim Investigational Site

    Osaka, Osaka, 553-0003

  • Boehringer Ingelheim Investigational Site

    Otaru, Hokkaido, 047-8550

  • Boehringer Ingelheim Investigational Site

    Oyama, Tochigi, 323-0022

  • Boehringer Ingelheim Investigational Site

    Sagamihara, Kanagawa, 228-8555

  • Boehringer Ingelheim Investigational Site

    Sagamihara, Kanagawa, 229-1125

  • Boehringer Ingelheim Investigational Site

    Sakai, Osaka, 590-0132

  • Boehringer Ingelheim Investigational Site

    Sakai, Osaka, 591-8025

  • Boehringer Ingelheim Investigational Site

    Sapporo, Hokkaido, 001-0023

  • Boehringer Ingelheim Investigational Site

    Sapporo, Hokkaido, 001-0024

  • Boehringer Ingelheim Investigational Site

    Sapporo, Hokkaido, 003-0023

  • Boehringer Ingelheim Investigational Site

    Sapporo, Hokkaido, 003-8585

  • Boehringer Ingelheim Investigational Site

    Sapporo, Hokkaido, 004-0053

  • Boehringer Ingelheim Investigational Site

    Sapporo, Hokkaido, 006-0811

  • Boehringer Ingelheim Investigational Site

    Sapporo, Hokkaido, 060-0033

  • Boehringer Ingelheim Investigational Site

    Sapporo, Hokkaido, 060-0062

  • Boehringer Ingelheim Investigational Site

    Sapporo, Hokkaido, 062-0007

  • Boehringer Ingelheim Investigational Site

    Sapporo, Hokkaido, 062-0931

  • Boehringer Ingelheim Investigational Site

    Sapporo, Hokkaido, 064-0953

  • Boehringer Ingelheim Investigational Site

    Sapporo, Hokkaido, 064-8622

  • Boehringer Ingelheim Investigational Site

    Sapporo, Hokkaido, 065-0027

  • Boehringer Ingelheim Investigational Site

    Sendai, Miyagi, 980-0021

  • Boehringer Ingelheim Investigational Site

    Sendai, Miyagi, 981-8501

  • Boehringer Ingelheim Investigational Site

    Setagaya-ku, Tokyo, 158-8531

  • Boehringer Ingelheim Investigational Site

    Seto, Aichi, 489-8642

  • Boehringer Ingelheim Investigational Site

    Shibetsu, Hokkaido, 095-0014

  • Boehringer Ingelheim Investigational Site

    Shibuya-ku, Tokyo, 150-0013

  • Boehringer Ingelheim Investigational Site

    Shibuya-ku, Tokyo, 150-8935

  • Boehringer Ingelheim Investigational Site

    Shinagawa, Tokyo, 140-8522

  • Boehringer Ingelheim Investigational Site

    Shinjuku-ku, Tokyo, 160-0023

  • Boehringer Ingelheim Investigational Site

    Shinjyuku-ku, Tokyo, 162-8666

  • Boehringer Ingelheim Investigational Site

    Shiojiri, Nagano, 399-0702

  • Boehringer Ingelheim Investigational Site

    Sunagawa, Hokkaido, 073-0196

  • Boehringer Ingelheim Investigational Site

    Takamatsu, Kagawa, 760-0018

  • Boehringer Ingelheim Investigational Site

    Takarazuka, Hyogo, 665-0827

  • Boehringer Ingelheim Investigational Site

    Takasaki, Gunma, 370-0069

  • Boehringer Ingelheim Investigational Site

    Takatsuki, Osaka, 569-1096

  • Boehringer Ingelheim Investigational Site

    Tama, Tokyo, 206-0025

  • Boehringer Ingelheim Investigational Site

    Toride, Ibaraki, 302-0022

  • Boehringer Ingelheim Investigational Site

    Tosu, Saga, 841-0061

  • Boehringer Ingelheim Investigational Site

    Toyohashi, Aichi, 441-8021

  • Boehringer Ingelheim Investigational Site

    Toyohashi, Aichi, 441-8570

  • Boehringer Ingelheim Investigational Site

    Toyota, Aichi, 471-8513

  • Boehringer Ingelheim Investigational Site

    Tsuchiura, Ibaraki, 300-0047

  • Boehringer Ingelheim Investigational Site

    Tsuchiura,Ibaraki, 300-0053

  • Boehringer Ingelheim Investigational Site

    Tsukuba, Ibaragi, 305-0812

  • Boehringer Ingelheim Investigational Site

    Uji, Kyoto, 611-0013

  • Boehringer Ingelheim Investigational Site

    Ushiku, Ibaraki, 300-1296

  • Boehringer Ingelheim Investigational Site

    Uwajima, Ehime, 798-8510

  • Boehringer Ingelheim Investigational Site

    Yokohama, Kanagawa, 222-0033

  • Boehringer Ingelheim Investigational Site

    Yokohama, Kanagawa, 227-0046

  • Boehringer Ingelheim Investigational Site

    Yokohama, Kanagawa, 227-0062

  • Boehringer Ingelheim Investigational Site

    Yokohama, Kanagawa, 235-0045

  • Boehringer Ingelheim Investigational Site

    Yokohama, Kanagawa, 236-0016

  • Boehringer Ingelheim Investigational Site

    Yokohama, Kanagawa, 240-8585

  • Boehringer Ingelheim Investigational Site

    Yokohama, Kanagawa, 247-0006

Other trials in Japan

About this study

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 -

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.

Read the 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.

Being tested
Telmisartan capsule 40 mg, Placebo, Telmisartan capsule 80 mg
Medical subject headings
Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telmisartan capsule 40 mgDrug

  • PlaceboDrug

  • Telmisartan capsule 80 mgDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Non-transition to overt nephropathy

Secondary outcomes (1)

  1. Change in renal parameters Composite endpoint

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startJan 2003
  3. Primary completionNov 2005
  4. Study completionNov 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
527 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00153088
Sponsor's protocol ID
502.413
Status last verified
Oct 2013
First submitted
9 Sep 2005
Last updated
1 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Telmisartan capsule 40 mg and Telmisartan capsule 80 mg in people with Diabetic Nephropathies, run by Boehringer Ingelheim at 160 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 160 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-transition to overt nephropathy. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00153088.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013.

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