NCT02722265

Brief Summary

To examine antihypertensive effect, pharmacodynamics, and safety of long-term administration of CS-3150 as monotherapy and in combination with calcium channel blocker or renin-angiotensin system inhibitor in patients with essential hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
368

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 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

Study Start

First participant enrolled

March 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2017

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

1.4 years

First QC Date

March 23, 2016

Last Update Submit

October 4, 2019

Conditions

Essential Hypertension

Keywords

Essential hypertensionLong-term treatmentMineralocorticoid receptor antagonist

Outcome Measures

Primary Outcomes (1)

  • change from baseline in sitting systolic and diastolic blood pressure

    week 0 (baseline) to end of weeks 12, 28, and 52

Secondary Outcomes (1)

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

    week 0 (baseline) to end of weeks 12, 28, and 52

Study Arms (1)

CS-3150

EXPERIMENTAL

CS-3150 2.5mg to 5mg, orally, once daily for 28 or 52 weeks

Drug: CS-3150

Interventions

CS-3150DRUG

CS-3150 2.5mg to 5mg, orally, once daily for 28 or 52 weeks

CS-3150

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, who do not receive any antihypertensive drugs or receive calcium channel blocker, angiotensin converting enzyme ACE inhibitor, or angiotensin-II receptor blockade ARB during run-in period (Sitting systolic blood pressure SBP ≥ 140 mmHg and \< 180 mmHg, Sitting diastolic blood pressure DBP ≥ 90 mmHg and \< 110 mmHg, and mean 24hr SBP ≥ 130 and DBP ≥ 80 mmHg)

You may not qualify if:

  • Secondary hypertension or malignant hypertension
  • Diabetes mellitus with albuminuria
  • Serum potassium level \< 3.5 or ≥ 5.1 mEq/L (≥ 4.8 mEq/L if receive ACE inhibitor, or ARB)
  • Reversed day-night life cycle including overnight workers
  • estimated glomerular filtration rate eGFR \< 60 mL/min/1.73 m\^2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Osaka, Japan

Location

Related Publications (1)

  • Ichikawa S, Tsutsumi J, Sugimoto K, Yamakawa S. Antihypertensive Effect of Long-Term Monotherapy with Esaxerenone in Patients with Essential Hypertension: Relationship Between Baseline Urinary Sodium Excretion and Its Antihypertensive Effect. Adv Ther. 2022 Oct;39(10):4779-4791. doi: 10.1007/s12325-022-02282-3. Epub 2022 Aug 17.

    PMID: 35976603DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

esaxerenone

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Global Clinical Leader

    Daiichi Sankyo Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2016

First Posted

March 29, 2016

Study Start

March 1, 2016

Primary Completion

July 8, 2017

Study Completion

July 8, 2017

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)