NCT02890173

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,001

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2017

Completed
Last Updated

December 21, 2018

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

August 29, 2016

Last Update Submit

December 19, 2018

Conditions

Essential Hypertension

Keywords

Essential hypertensionMineralocorticoid receptor antagonistEsaxerenoneAmbulatory blood pressure monitoring

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in sitting blood pressure

    Change from baseline in sitting systolic (SBP) and diastolic blood pressure (DBP).

    Baseline to end of Week 12

Secondary Outcomes (1)

  • Change from baseline in 24 hour average blood pressure

    Baseline to end of Week 12

Study Arms (3)

CS-3150 2.5 mg

EXPERIMENTAL

CS-3150 2.5 mg, orally, once daily after breakfast for 12 weeks

Drug: CS-3150

CS-3150 5.0 mg

EXPERIMENTAL

CS-3150 5 mg, orally, once daily after breakfast for 12 weeks

Drug: CS-3150

Eplerenone

ACTIVE COMPARATOR

Eplerenone 50 mg, orally, once daily after breakfast for 12 weeks

Drug: Eplerenone

Interventions

CS-3150DRUG
CS-3150 2.5 mgCS-3150 5.0 mg
EplerenoneDRUG
Also known as: Inspra
Eplerenone

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Related Publications (1)

  • 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.

    PMID: 31786983DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

esaxerenoneEplerenone

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Global Clinical Leader

    Daiichi Sankyo Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 7, 2016

Study Start

September 1, 2016

Primary Completion

July 11, 2017

Study Completion

July 11, 2017

Last Updated

December 21, 2018

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

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/

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.
More information

Locations

JP(1)