BAY94-8862
DrugTwo 1.25 mg BAY94-8862 and 2 placebo tablets for duration of 4 weeks
NCT Number: NCT01345656
A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Graz, Styria, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two 1.25 mg BAY94-8862 and 2 placebo tablets for duration of 4 weeks
Placebo tablets for duration of 4 weeks
Part B only: 25 mg spironolactone once daily with up-titration to 50 mg once daily starting at day 15, if serum potassium is less or equal to 4.8 mmol/L, for duration of 4 weeks
Time frame: 4 weeks
Time frame: Day 8, Day 15, Day 22, Day 29
Time frame: Day 8, Day 15, Day 22, Day 29
Time frame: Day 8, Day 15, Day 22, Day 29
Bayer
Industry
A Randomized, Double-blind, Multi-center Study to Assess Safety and Tolerability of Different Oral Doses of BAY94-8862 in Subjects With Stable Chronic Heart Failure With Left Ventricular Systolic Dysfunction and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease Versus Placebo (Part A) or Versus Placebo and Spironolactone (Part B)
Acronym: ARTS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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