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A Phase 2 Exploratory Study to evaluate efficacy and safety of CS-3150 in Japanese Hypertensive Patients with Moderate Kidney Dysfunction

A Phase 2 Exploratory Study to evaluate efficacy and safety of CS-3150 in Japanese Hypertensive Patients with Moderate Kidney Dysfunction

33

The FAS(33 subjects) were male subjects 72.7%, mean age 63.9 years, mean systolic blood pressure153.6 mmHg, and mean diastolic blood pressure 93.4 mmHg, mean UACR, 16.69 mg/g.Cr.

33 subjects were registered and received CS-3150. Three subjects of them discontinued the study and 30 subjects completed the study. The reasons for discontinuation were adverse events in 2 subjects and other events in 1 subject. A total of 33 subjects were included in the FAS and Safety-Analysis Sets.

The incidence of adverse events was 63.6% (21/33). Of these, the incidence of AEs considered to be related to the study drug was 24.2% (8/33). The severity was moderate in 1 subject, and all other events were mild and none of the events were judged to be severe. Neither death nor other serious adverse events were observed.

- Change in sitting blood pressure The arithmetic mean (95% CI) of the change in sitting blood pressure was-18.5 (-23.7 to-13.3) mmHg in systolic blood pressure and-8.8 (-11.9 to-5.7) mmHg in diastolic blood pressure, and the blood pressure at the end of treatment significantly decreased in both systolic and diastolic blood pressure than the baseline blood pressure (paired t-test, P < 0.0001).

- Change in sitting blood pressure The arithmetic mean (SD) of sitting blood pressure was 153.6 (7.33) mmHg in systolic blood pressure and 93.4 (6.71) mmHg in diastolic blood pressure during the run-in period. Systolic blood pressure and diastolic blood pressure decreased from the day after commencement of administration of the study drug, and then decreased until 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 63.6% (45.1% to 79.6%). 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 48.5% (30.8% to 66.5%).

The efficacy and safety of CS-3150 titrated from 1. 25 mg, 2.5 mg to 5 mg were investigated in hypertensive patients with moderate kidney dysfunction for 12 weeks. The change in sitting blood pressure was significantly decreased in both systolic and diastolic blood pressures, and the change in sitting blood pressure decreased until Week 12 of the treatment period, demonstrating the hypotensive effects of CS-3150. No notable safety concerns were identified and tolerability was confirmed.

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

DAIICHISANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

completed

May. 23, 2015

Interventional

This is a multi-center, open label, dose titration study.

treatment purpose

2

1) Male and female subjects aged 20 years or older and 80 years or younger at informed consent
2) Subjects with hypertension (Sitting SBP >= 140 mmHg and < 180 mmHg, Sitting DBP >= 80 mmHg and < 110 mmHg)
3) eGFR >= 30 mL/min/1.73 m2 and < 60 mL/min/1.73 m2

1) Secondary hypertension (except renoparenchymal hypertension) or malignant hypertension
2) Diabetes mellitus with albuminuria
3) Serum potassium level < 3.5 or >= 5.1 mEq/L
4) Subjects under Insulin treatment
5) Subjects under or pre-planned for hemodialysis

Both

Hypertension with moderate kidney dysfunction

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
- Adverse events

safety
efficacy
- Time course of sitting systolic and diastolic blood pressure
- Proportion of patients achieving sitting blood pressure control
- Change from baseline in urinary albumin creatinine ratio
- Change in serum potassium

-

April. 16, 2015