Phase IIa Study to Investigate the Efficacy and Safety of SPP635 in Diabetic and Hypertensive Patients With Albuminuria
NCT ID: NCT00561171
Last Updated: 2008-11-21
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
PHASE2
50 participants
INTERVENTIONAL
2007-11-30
2008-09-30
Brief Summary
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The total study duration for patients completing the entire study will be approximately 7 weeks including a 2 weeks Screening Phase, 1 week Wash-out Phase, 4 week Treatment Phase and 1 week Follow-up Phase.
All treatments other than certain antihypertensive drugs (which are to be washed-out) with an effect on BP and all antidiabetic treatments must be kept at stable dose during the whole study.
A maximum of 50 patients in total is planned to be enrolled.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
high dose
SPP635
oral once daily
2
lower dose
SPP635
oral once daily
Interventions
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SPP635
oral once daily
Eligibility Criteria
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Inclusion Criteria
* hypertension
* diabetes mellitus type II
* albuminuria
Exclusion Criteria
* significant illness
* history of malignancy
* Heart failure, stroke, myocardial infarction, transient ischaemic attack, or hypertensive encephalopathy within the past 6 months
* Current or past history of clinically significant electrocardiogram (ECG) abnormalities such as permanent 2nd degree atrioventricular (AV) block or higher, unstable angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG) or cerebrovascular accident in the last three months
18 Years
75 Years
ALL
No
Sponsors
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Speedel Pharma Ltd.
INDUSTRY
Responsible Party
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Novartis Pharma AG
Principal Investigators
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Maria Nicolaides, Dr.
Role: STUDY_DIRECTOR
Speedel Pharma Ltd.
Locations
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Dr. John Barton
Ballinasloe, Co Galway, Ireland
Countries
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Other Identifiers
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SPP635CRD05
Identifier Type: -
Identifier Source: org_study_id