Study of CS-3150 in Patients With Essential Hypertension (ESAX-HTN)
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|ClinicalTrials.gov Identifier: NCT02890173|
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : December 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Essential Hypertension||Drug: CS-3150 Drug: Eplerenone||Phase 3|
Primary objective is to evaluate antihypertensive effect and safety of CS-3150 2.5 mg compared to Eplerenone in patients with essential hypertension.
Secondary objective is to evaluate antihypertensive effect and safety of CS-3150 5.0 mg compared to 2.5 mg.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1001 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double Blind Study of CS-3150 to Evaluate Efficacy and Safety Compared to Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study)|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||July 11, 2017|
|Actual Study Completion Date :||July 11, 2017|
Experimental: CS-3150 2.5 mg
CS-3150 2.5 mg, orally, once daily after breakfast for 12 weeks
Experimental: CS-3150 5.0 mg
CS-3150 5 mg, orally, once daily after breakfast for 12 weeks
Active Comparator: Eplerenone
Eplerenone 50 mg, orally, once daily after breakfast for 12 weeks
Other Name: Inspra
- Change from baseline in sitting blood pressure [ Time Frame: Baseline to end of Week 12 ]Change from baseline in sitting systolic (SBP) and diastolic blood pressure (DBP).
- Change from baseline in 24 hour average blood pressure [ Time Frame: Baseline to end of Week 12 ]Change from baseline in 24 hour average systolic and diastolic blood pressure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890173
|Sapporo, Hokkaido, Japan|
|Study Director:||Global Clinical Leader||Daiichi Sankyo Co., Ltd.|