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Study of CS-3150 in Patients With Essential Hypertension (ESAX-HTN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890173
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Brief Summary:
To evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone in patients with essential hypertension.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: CS-3150 Drug: Eplerenone Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1001 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone

Arm Intervention/treatment
Experimental: CS-3150 2.5 mg
CS-3150 2.5 mg, orally, once daily after breakfast for 12 weeks
Drug: CS-3150
Experimental: CS-3150 5.0 mg
CS-3150 5 mg, orally, once daily after breakfast for 12 weeks
Drug: CS-3150
Active Comparator: Eplerenone
Eplerenone 50 mg, orally, once daily after breakfast for 12 weeks
Drug: Eplerenone
Other Name: Inspra




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects aged 20 years or older at informed consent
  • 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:

  • Secondary hypertension or malignant hypertension
  • 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

Information from the National Library of Medicine

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


Locations
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Japan
Sapporo, Hokkaido, Japan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
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Study Director: Global Clinical Leader Daiichi Sankyo Co., Ltd.

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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02890173     History of Changes
Other Study ID Numbers: CS3150-A-J301
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
Essential hypertension
Mineralocorticoid receptor antagonist
Esaxerenone
Ambulatory blood pressure monitoring
Additional relevant MeSH terms:
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Eplerenone
Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents