Status:
COMPLETED
INNOVATION Study - Telmisartan (Micardis) in Incipient Diabetic Nephropathy
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetic Nephropathies
Eligibility:
All Genders
30-74 years
Phase:
PHASE4
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 micro...
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 Telmisa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
527 Patients enrolled
Trial Details
Trial ID
NCT00153088
Start Date
January 1 2003
End Date
November 1 2005
Last Update
November 1 2013
Active Locations (160)
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1
Boehringer Ingelheim Investigational Site
Adachi-ku, Tokyo, Japan, 121-0813
2
Boehringer Ingelheim Investigational Site
Amagasaki, Hyogo, Japan, 661-0002
3
Boehringer Ingelheim Investigational Site
Arakawa-ku, Tokyo, Japan, 116-0011
4
Boehringer Ingelheim Investigational Site
Asaguchi-gun, Okayama, Japan, 719-0113