Study of CS-3150 in Patients With Essential Hypertension
NCT ID: NCT02890173
Last Updated: 2018-12-21
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
PHASE3
1001 participants
INTERVENTIONAL
2016-09-30
2017-07-11
Brief Summary
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Detailed Description
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Secondary objective is to evaluate antihypertensive effect and safety of CS-3150 5.0 mg compared to 2.5 mg.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CS-3150 2.5 mg
CS-3150 2.5 mg, orally, once daily after breakfast for 12 weeks
CS-3150
CS-3150 5.0 mg
CS-3150 5 mg, orally, once daily after breakfast for 12 weeks
CS-3150
Eplerenone
Eplerenone 50 mg, orally, once daily after breakfast for 12 weeks
Eplerenone
Interventions
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CS-3150
Eplerenone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with essential hypertension satisfying the following blood pressure criteria;
* Sitting SBP: ≥ 140 mmHg and \< 180 mmHg
* Sitting DBP: ≥ 90 mmHg and \< 110 mmHg
* Mean 24 hr BP: SBP ≥ 130 and DBP ≥ 80 mmHg
Exclusion Criteria
* Diabetic nephropathy or 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 Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo Co., Ltd.
Locations
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Sapporo, Hokkaido, Japan
Countries
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References
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Ito S, Itoh H, Rakugi H, Okuda Y, Yoshimura M, Yamakawa S. Double-Blind Randomized Phase 3 Study Comparing Esaxerenone (CS-3150) and Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study). Hypertension. 2020 Jan;75(1):51-58. doi: 10.1161/HYPERTENSIONAHA.119.13569. Epub 2019 Dec 2.
Other Identifiers
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CS3150-A-J301
Identifier Type: -
Identifier Source: org_study_id