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A Study of CS-3150 to Evaluate Efficacy and Safety to in combination with ARB or ACE inhibitor in Hypertensive Patients with Moderate Kidney Dysfunction

A Study of CS-3150 to Evaluate Efficacy and Safety to in combination with ARB or ACE inhibitor in Hypertensive Patients with Moderate Kidney Dysfunction

58

The FAS(58 subjects) were male 77.6%, the mean age 68.0 years, and the mean sitting blood pressure 159.4 mmHg for systolic blood pressure and 91.8 mmHg for diastolic blood pressure.

58 enrolled subjects started receiving CS-3150 1.25mg. Of these, three patients discontinued the study and 55 completed the study. 54 subjects were receiving CS-3150 2.5 mg or 5mg. The reasons for discontinuation were adverse events in 1 subject and other events in 2 subjects. All of 58 subjects were included in the FAS and safety analysis set.

The incidence of adverse events was 60.3% (35/58). Of these, the incidence of AEs considered related to the event drug was 29.3% (17/58). All adverse events were assessed as mild in severity. No deaths or serious adverse events were reported.

- Change in sitting blood pressure The point estimate (95% confidence interval)in sitting BP was-17.8 (-21.0 to-14.7) mmHg for systolic BP and-8.1 (-9.7 to-6.5) mmHg for diastolic BP. At the end of treatment, both systolic and diastolic blood pressures significantly decreased relative to baseline blood pressure (paired t-test, P < 0.0001 for both).

- Change in sitting blood pressure Both systolic and diastolic blood pressures in the sitting position continued to decrease from Week 1 to Week 12. - Proportion of patients achieving the target of sitting BP reduction The point estimate (95% confidence interval) of the percentage of subjects achieving the target blood pressure reduction when the target blood pressure in the sitting position was set at <140/90 mmHg (Criterion 1) was 48.3% (35.0-61.8%). When the target blood pressure was set at <130/80 mmHg in subjects with diabetes mellitus and <140/90 mmHg in subjects without diabetes mellitus (Criteria 2), the point estimate (95% confidence interval) of the percentage of subjects achieving the target BP reduction was 39.7% (27.0% to 53.4%).

The efficacy and safety of CS-3150 titrated from 1. 25 mg, 2.5 mg to 5 mg, in combination with ARB or ACE inhibitors were investigated in hypertensive patients with moderate kidney dysfunction for 12 weeks. In the evaluation of the change in sitting blood pressure, the blood pressure value at the end of treatment significantly decreased both systolic and diastolic blood pressure compared with the baseline blood pressure value in the run-in period. No safety issues were observed.

Yes

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/ Supporting Documents: - Study Protocol - Statistical Analysis Plan - Clinical Study Report 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. URL: https://vivli.org/ourmember/daiichi-sankyo/

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

completed

June. 23, 2016

Interventional

Multi-center, open label, dose titration study

treatment purpose

3

) Male and female subjects aged 20 or older to 80 years or younger at informed consent
2) Subjects with hypertension (i)Sitting SBP >= 140 mmHg, <180 mmHg and Sitting DBP >= 80 mmHg, <110 mmHg, ii) between two measurement difference =<30/15 mmHg at run-in period)
3) eGFR >= 30 mL/min/1.73m2 and < 60 mL/min/1.73m2
4) Treated with an ARB or ACE inhibitor

1) Secondary hypertension (except renoparenchymal hypertension) or malignant hypertension
2) Diabetes mellitus with albuminuria
3) Subjects under Insulin treatment
4) Subjects under or pre-planned for hemodialysis
5) Serum potassium level < 3.5 or >= 4.8 mEq/L

Both

Hypertension with moderate renal impairment

investigational material(s)
Generic name etc : CS-3150
INN of investigational material : Esaxerenone
Therapeutic category code : 214 Antihypertensives
Dosage and Administration for Investigational material : Each subject will orally take the study drug once daily after breakfast for 12 weeks

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

safety
efficacy
- Change from baseline in sitting systolic and diastolic blood pressure at the end of treatment
- Adverse events

efficacy
-Time course of sitting systolic and diastolic blood pressure
-Proportion of patients achieving sitting blood pressure control

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May. 16, 2016