A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Subjects
NCT ID: NCT02345044
Last Updated: 2019-10-08
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
426 participants
INTERVENTIONAL
2015-01-31
2015-10-31
Brief Summary
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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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CS-3150 1.25 mg
One CS-3150 1.25 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
CS-3150
placebo
CS-3150 2.5 mg
Two CS-3150 1.25 mg tablets administered orally, once daily after breakfast.
CS-3150
CS-3150 5 mg
Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast.
CS-3150
Placebo
Two placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast.
placebo
Eplerenone, 50-100 mg (Open Label)
One or two 50mg eplerenone tablet(s) administered orally, once daily after breakfast.
eplerenone
Interventions
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CS-3150
placebo
eplerenone
Eligibility Criteria
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Inclusion Criteria
* Subjects with essential hypertension (Sitting SBP ≥ 140 mmHg and \< 180 mmHg, Sitting DBP ≥ 90 mmHg and \< 110 mmHg,and 24h-hr blood pressure more than 130 mmHg in SBP and 80 mmHg in DBP)
Exclusion Criteria
* Diabetes mellitus with albuminuria
* Serum potassium level \< 3.5 or ≥ 5.1 mEq/L
* Reversed day-night life cycle including overnight workers
* eGFR \< 60 mL/min/1.73 m\^2
20 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Locations
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Osaka, , Japan
Countries
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Other Identifiers
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CS3150-A-J203
Identifier Type: -
Identifier Source: org_study_id
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