Status:
COMPLETED
A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare Telmisartan (MICARDIS) 80 mg Versus Losartan (COZAAR) 100 mg, in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy (AMADEO Study)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension
Diabetic Nephropathies
Eligibility:
All Genders
21-80 years
Phase:
PHASE4
Brief Summary
A number of blood pressure lowering drugs in the class known as angiotensin receptor blockers (ARB) have been shown to slow the decline in kidney function of patients with type 2 diabetes, high blood ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age 21-80 years
- Clinical history of type 2 diabetes mellitus, as defined by either:
- Hyperglycaemia not requiring insulin (diet, oral hypoglycaemic agents and metformin if patients serum creatinine levels were within normal limits.)
- Hyperglycaemia requiring insulin with: no history of diabetic ketoacidosis AND with either the period between diagnosis and insulin usage \>1 year or elevated fasting or stimulated C-peptide level
- Glycosylated haemoglobin A1 (HbA1c) ≤10%
- Diabetic nephropathy, as defined by:
- serum creatinine at Screening (Visit 1) ≤265 μmol/L (3.0 mg/dL) in women and ≤283 μmol/L (3.2 mg/dL) in men
- urinary protein/creatinine ratio ≥700 mg/g (measured in spot urine) during the run-in phase (Visit 2 or Visit 5 retest)
- Hypertension at screening, as defined by either:
- Mean systolic blood pressure (SBP) \>130 mmHg and/or mean diastolic blood pressure (DBP) \>80 mmHg in untreated patients
- Patients currently receiving antihypertensive medication (i.e. medications specifically prescribed to treat hypertension)
- Ability to stop current antihypertensive therapy with Angiotensin Converting Enzyme Inhibitor (ACE-Is), Angiotensin Receptor Blockers (ARBs) and direct vasodilators, and to stop chronic immunosuppressive therapy and current therapy with metformin without risk to the patient (Investigator's discretion).
- All female patients had to have negative results from the urine pregnancy test (UPT) at Visits 1 and 6 in order to be able to continue in the study.
- Exclusion criteria:
- Pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who:
- were not surgically sterile or
- were nursing or pregnant or
- were of child-bearing potential and were not practicing acceptable methods of birth control, or did not plan to continue practicing an acceptable method throughout the study (Note: Acceptable methods of birth control included transdermal patch, intra-uterine device, oral, implantable or injectable contraceptives) AND did not agree to periodic urine pregnancy testing (UPT) during participation in the study. No exceptions were made.
- Type 1 diabetes mellitus
- Increase of serum creatinine \>35% between Visit 1 (Screening) and Visit 5. If creatinine was increased \>35% at Visit 5, the measurement was to be repeated within five calendar days and if the increase was confirmed, the patient had to be excluded from the trial for safety reasons.
- Non-diabetic renal disease
- Congestive heart failure (New York Heart Association functional class III or IV)
- Unstable angina, myocardial infarction, coronary artery bypass graft surgery, or percutaneous coronary intervention within the last three months prior to signing the informed consent form
- Stroke or transient ischaemic attack within the last six months prior to signing the informed consent form
- Hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
- Further exclusion criteria apply
Exclusion
Key Trial Info
Start Date :
July 9 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
860 Patients enrolled
Trial Details
Trial ID
NCT00168857
Start Date
July 9 2003
Last Update
December 8 2023
Active Locations (109)
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1
Boehringer Ingelheim Investigational Site
Montgomery, Alabama, United States
2
Boehringer Ingelheim Investigational Site
Little Rock, Arkansas, United States
3
Boehringer Ingelheim Investigational Site
Lancaster, California, United States
4
Boehringer Ingelheim Investigational Site
Los Angeles, California, United States