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INNOVATION Study - Telmisartan (Micardis) in Incipient Diabetic Nephropathy

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Completed
Phase 4

Conditions

Diabetic Nephropathies

Treatments

Drug: Telmisartan capsule 80 mg
Drug: Placebo
Drug: Telmisartan capsule 40 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00153088
502.413

Details and patient eligibility

About

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.

Full 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.

Enrollment

527 patients

Sex

All

Ages

30 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Outpatients who are able to visit the study site throughout the run-in period
  2. Aged 30 and 74 years
  3. Type II diabetes mellitus
  4. 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
  5. Serum creatinine level of < 1.5 mg/dL in male and < 1.3 mg/dL in female
  6. Normotensive or hypertensive patients
  7. Patients taking AT1 antagonists or ACE inhibitors at screening, but are able to stop those drugs during the study
  8. 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

  1. Age of onset of type 2 diabetes is < 30 years

  2. Type I diabetes

  3. Urinary albumin to creatinine ratio of > 300 mg/g Creatinine

  4. HbA1c 9%

  5. Seated SBP 180 mmHg or DBP 110 mmHg

  6. 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

  7. 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
  8. History of angioedema during administration of ARB/ACE-i

  9. Hypersensitivity

  10. History of sudden exacerbation of renal function due to ARB/ACE-i

  11. Markedly poor bile secretion

  12. Hepatic dysfunction: SGPT (ALT) or SGOT (AST) 100 IU/L

  13. Serum potassium level < 3.5 mEq/L or 5.1 mEq/L

  14. Unable to discontinue ARB/ACE-i

  15. Require prolonged administration of any medications affecting blood pressure, except diuretics, or blockers, and CCB

  16. Untreated sodium depletion

  17. 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.
  18. Malignant tumour or other diseases requiring oral or injection immunosuppressants

  19. Non-compliance

  20. History of drug or alcohol abuse

  21. Participated in other clinical studies within 3 months

  22. Any other conditions investigators judged as ineligible

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

160

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Data sourced from clinicaltrials.gov

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