NCT02345044

Brief Summary

This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese hypertensive subjects. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
426

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

January 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

January 19, 2015

Last Update Submit

October 4, 2019

Conditions

Essential Hypertension

Keywords

Essential hypertensionmineralocorticoid receptor antagonistCS-3150Japanese

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in sitting systolic and diastolic blood pressure

    baseline to end week 12

Secondary Outcomes (1)

  • Change from baseline in 24-hr blood pressure (ABPM)

    Baseline to end week 12

Study Arms (5)

CS-3150 1.25 mg

EXPERIMENTAL

One CS-3150 1.25 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.

Drug: CS-3150Drug: placebo

CS-3150 2.5 mg

EXPERIMENTAL

Two CS-3150 1.25 mg tablets administered orally, once daily after breakfast.

Drug: CS-3150

CS-3150 5 mg

EXPERIMENTAL

Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast.

Drug: CS-3150

Placebo

PLACEBO COMPARATOR

Two placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast.

Drug: placebo

Eplerenone, 50-100 mg (Open Label)

ACTIVE COMPARATOR

One or two 50mg eplerenone tablet(s) administered orally, once daily after breakfast.

Drug: eplerenone

Interventions

CS-3150DRUG
CS-3150 1.25 mgCS-3150 2.5 mgCS-3150 5 mg
placeboDRUG
CS-3150 1.25 mgPlacebo
eplerenoneDRUG
Eplerenone, 50-100 mg (Open Label)

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 (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)

You may not qualify if:

  • Secondary hypertension or malignant hypertension
  • 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

Osaka, 530-0001, Japan

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

esaxerenoneEplerenone

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
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

January 19, 2015

First Posted

January 26, 2015

Study Start

January 1, 2015

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

October 8, 2019

Record last verified: 2019-10

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, CSR
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)