Back to results

A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Subjects

Primary Purpose

Essential Hypertension

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

CS-3150

placebo

eplerenone

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Essential hypertension, mineralocorticoid receptor antagonist, CS-3150, Japanese

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

CS-3150 1.25 mg

CS-3150 2.5 mg

CS-3150 5 mg

Placebo

Eplerenone, 50-100 mg (Open Label)

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

Change from baseline in sitting systolic and diastolic blood pressure

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02345044

First Posted

January 19, 2015

Last Updated

October 4, 2019

Sponsor

Daiichi Sankyo, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02345044

Brief Title

A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Subjects

Official Title

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Subjects With Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Daiichi Sankyo, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Essential Hypertension

Keywords

Essential hypertension, mineralocorticoid receptor antagonist, CS-3150, Japanese

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

426 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CS-3150 1.25 mg

Arm Type

Experimental

Arm Description

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

Arm Title

CS-3150 2.5 mg

Arm Type

Experimental

Arm Description

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

Arm Title

CS-3150 5 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Eplerenone, 50-100 mg (Open Label)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

CS-3150

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Type

Drug

Intervention Name(s)

eplerenone

Primary Outcome Measure Information:

Title

Change from baseline in sitting systolic and diastolic blood pressure

Time Frame

baseline to end week 12

Secondary Outcome Measure Information:

Title

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

Time Frame

Baseline to end week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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

Facility Information:

City

Osaka

ZIP/Postal Code

530-0001

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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/

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing URL

https://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Subjects

We'll reach out to this number within 24 hrs