Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2003-05-31
2004-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Olmesartan medoxomil
Losartan
Eligibility Criteria
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Inclusion Criteria
* Greater than or equal to 30 years of age
* Type 2 diabetes first diagnosed at greater than or equal to 30 years of age
* Urinary protein excretion between 200-4000 mg/day exclusive
* Mean sitting dBP less than or equal to 110 mgHg
* Medically justifiable to withdraw antihypertensive treatment due to poor tolerability or inefficacy of previous treatment, or verification that treatment is still necessary
Exclusion Criteria
* Secondary forms of hypertension other than diabetic nephropathy, malignant hypertension or patients with sitting dBP exceeding 110 mmHg or sitting sBP exceeding 200 mmHg
* ECG evidence of 2nd or 3rd degree AV-block, atrial fibrillation, cardiac arrhythmia (requiring therapy) or bradycardia
* Presence of significant cardiovascular disease
* Significant cerebrovascular disease, gastrointestinal, haematological or hepatic disease or myocardial infarction in last 12 months or a previous history of any serious underlying disease
* Concurrent renal disease, nephrectomy and/or renal transplant, serum creatinine level greater than or equal to 2.0 mg/dL or creatinine clearance CLCR less than or equal to 50 mL/min
* Clinically significant lab abnormalities (ASAT/SGOT, ALAT/SGPT and γ-GT )
* Serum potassium level \< 2.5 mmol/L or \> 5.5 mmol/L
* Treatment of concurrent indications with drugs or medication which could have influenced BP
* History of hypersensitivity, lack of response or contraindication to Ang II-antagonists, HCTZ or atenolol, or hypersensitivity to related drugs (cross-allergy)
30 Years
ALL
No
Sponsors
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Sankyo Pharma Gmbh
INDUSTRY
Principal Investigators
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H Haller, MD
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Locations
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Frýdlant, , Czechia
Liberec, , Czechia
Prague, , Czechia
Tartu, , Estonia
Augsburg, , Germany
Greifenstein-Beilstein, , Germany
Hanover, , Germany
Zwijndrecht, , Netherlands
Grodzisk Mazowiecki, , Poland
Krakow, , Poland
Poznan, , Poland
Pruszków, , Poland
Płock, , Poland
Torun, , Poland
Warsaw, , Poland
Watlack, , Poland
Wołomin, , Poland
Wroclaw, , Poland
Banská Bystrica, , Slovakia
Košice, , Slovakia
Lučenec, , Slovakia
Martin, , Slovakia
Nitra, , Slovakia
Nové Zámky, , Slovakia
Šahy, , Slovakia
Barcelona, , Spain
Madrid, , Spain
Countries
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Other Identifiers
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SE-866/29
Identifier Type: -
Identifier Source: org_study_id