NCT00153088|CompletedPhase 4

INNOVATION Study - Telmisartan (Micardis) in Incipient Diabetic Nephropathy

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 -

Boehringer Ingelheim ClinicalTrials.gov

Compare

1 other identifier

502.413

Study Type

interventional

Target

527

Locations

1 country

Sites

160

Timeline

RegisteredSep 2005

StartedJan 2003

CompletionNov 2005

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

527

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Jan 2003

Typical duration for phase_4

Geographic Reach

1 country

160 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.8 years study duration

Study Start

First participant enrolled

January 1, 2003

Completed

2.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed

Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

2.8 years

First QC Date

September 9, 2005

Last Update Submit

October 31, 2013

Conditions

Diabetic Nephropathies

Outcome Measures

Primary Outcomes (1)

Non-transition to overt nephropathy

Secondary Outcomes (1)

Change in renal parameters Composite endpoint

Interventions

Telmisartan capsule 40 mgDRUG

PlaceboDRUG

Telmisartan capsule 80 mgDRUG

Eligibility Criteria

Age30 Years - 74 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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
+18 more criteria

Contact the study team to confirm eligibility.