Single Dose Escalation Study in Patients With Chronic Heart Failure
NCT ID: NCT00565565
Last Updated: 2016-08-10
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
PHASE1
55 participants
INTERVENTIONAL
2007-10-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BAY60-4552, 1 mg
Subjects were planned to receive 1 mg of BAY60-4552 as solution
BAY60-4552
Single dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg
BAY60-4552, 2.5 mg
Subjects were planned to receive 2.5 mg of BAY60-4552 as tablet
BAY60-4552
Single dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg
BAY60-4552, 5 mg
Subjects were planned to receive 5.0 mg of BAY60-4552 as tablet
BAY60-4552
Single dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg
BAY60-4552, 7.5 mg
Subjects were planned to receive 7.5 mg of BAY60-4552 as tablet
BAY60-4552
Single dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg
BAY60-4552, 10 mg
Subjects were planned to receive 10 mg of BAY60-4552 as tablet
BAY60-4552
Single dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg
Interventions
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BAY60-4552
Single dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Bad Nauheim, Hesse, Germany
Giessen, Hesse, Germany
Countries
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References
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Acute hemodynamic response to single oral doses of BAY 60-4552, a soluble guanylate cyclase stimulator, in patients with biventricular heart failure. V Mitrovic, B Swidnicki, A Ghofrani, W Mück, N Kirschbaum, J Mittendorf, J-P Stasch, G Wensing, R Frey, S Lentini. BMC Pharmacology 2009; 9(Suppl 1): P51.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Other Identifiers
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2007-003216-54
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12356
Identifier Type: -
Identifier Source: org_study_id
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