NCT02848170

Brief Summary

Phase 3 study to examine the relation between antihypertensive effect and baseline factors exploratively, compared to olmesartan medoxomil in patients with essential hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

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

July 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

December 21, 2018

Status Verified

May 1, 2017

Enrollment Period

8 months

First QC Date

July 26, 2016

Last Update Submit

December 19, 2018

Conditions

Essential Hypertension

Keywords

essential hypertensionmineralocorticoid receptor antagonistDevelopmental Phase III

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in 24 hr blood pressure

    Relationship between the change from baseline in 24 hr blood pressure (systolic, diastolic, and average blood pressure) and baseline factors frpm baseline to end of Week 12

    baseline to end of Week 12

Secondary Outcomes (4)

  • Change from baseline in morning, evening, and night blood pressure.

    baseline to week 12

  • Change from baseline in sitting blood pressure

    baseline to week 12

  • Time course of 24 hr blood pressure and sitting blood pressure

    week 12

  • Proportion of patients achieving 24 hr and sitting blood pressure control

    week 12

Study Arms (2)

CS-3150

EXPERIMENTAL

CS-3150 2.5 to 5mg, orally, once daily after breakfast for 12 weeks

Drug: CS-3150

olmesartan medoxomil

ACTIVE COMPARATOR

olmesartan medoxomil 10 to 20 mg, orally, once daily after breakfast for 12 weeks

Drug: olmesartan medoxomil

Interventions

CS-3150DRUG

CS-3150 2.5mg, oral

CS-3150
olmesartan medoxomilDRUG

olmesartan medoxomil 10 mg, oral

Also known as: Benicar
olmesartan medoxomil

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 during run-in period (mean 24 hour systolic blood pressure SBP ≥ 130 and diastolic blood pressure DBP ≥ 80 mmHg and Sitting systolic blood pressure (SBP) ≥ 140 mmHg and \< 180 mmHg, Sitting diastolic blood pressure (DBP) ≥ 90 mmHg and \< 110 mmHg)

You may not qualify if:

  • Secondary hypertension or malignant hypertension
  • Diabetes mellitus with albuminuria
  • Serum potassium level \< 3.5 or ≥ 5.1 milliequivalent (mEq)/L
  • 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

Tokyo, Japan

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

esaxerenoneOlmesartan Medoxomil

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • Global Clinical Leader

    Daiichi Sankyo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2016

First Posted

July 28, 2016

Study Start

August 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

December 21, 2018

Record last verified: 2017-05

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)