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A Study of CS-3150 to Evaluate Efficacy and Safety in Patients with Primary Aldosteronism

A Study of CS-3150 to Evaluate Efficacy and Safety in Patients with Primary Aldosteronism

44

The FAS(44 subjects) were male 43.2%, the mean age 49.6 years, and the mean sitting BP of 154.0 mmHg and a diastolic BP of 100.0 mmHg .

The FAS (44 subjects) began to receive CS-3150 2.5 mg, 41 of whom had their dose increased to 5 mg. Of these, 3 subjects were withdrawn from the study and 41 subjects completed the study. The reasons for discontinuation were adverse events in 2 subjects and consent withdrawal in 1 subject. All of 44 patients were included in the FAS and safety analysis sets.

The incidence of adverse events was 61.4% (27/44), and the incidence of adverse events considered related to the study drug was 25.0% (11/44). A serious adverse event occurred in 1 subject. No adverse events were judged to be severe, 5 subjects were moderate in severity, and all other adverse events were judged to be mild.

- Change in sitting blood pressure Point estimates of change from run-in (95% confidence interval) were-17.7 (-20.6 to-14.7) mmHg for systolic blood pressure and-9.5 (-11.7 to-7.3) mmHg for diastolic blood pressure. At the end of treatment, both systolic and diastolic blood pressures significantly decreased relative to baseline blood pressure values in the run-in period (paired t-test, P < 0.0001 for both).

- Change in sitting blood pressure Both systolic and diastolic blood pressure continued to decrease after the decrease at Week 2 and remained almost constant from Week 8 to Week 12. - Proportion of patients achieving the target of sitting BP reduction The point estimate (95% confidence interval) of the percentage of subjects who achieved the target blood pressure in the sitting position was 47.7% (32.5% to 63.3%) at the end of treatment when the target blood pressure in the sitting position was set at <140/90 mmHg (Criterion 1). 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 40.9% (26.3% to 56.8%) at the completion of treatment.

The efficacy and safety of CS-3150 2.5mg administered once daily until 5 mg f was evaluated in patients with primary aldosteronism or 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

Oct. 04, 2016

Interventional

Multi-center, open label, dose titration study

treatment purpose

3

1) Male and female subjects aged 20 years or older at informed consent
2) Patients diagnosed primary aldosteronism by screening test of PAC and ARR, and confirmatory testing
3) Patients satisfying following blood pressure;
i)-sitting SBP >= 140 mmHg and <180 mmHg
-sitting DBP >= 90 mmHg and <110 mmHg,
ii) between two measurement difference =<30/15 mmHg)

1) Secondary hypertension except primary aldosteronism or hypertensive emergency
2) Patients diagnosed diabetic nephropathy
3) Patients with type 1 diabetes
4) eGFR < 30 mL/min/1.73m2
5) Serum potassium level < 3.0 or >= 5.1 mEq/L

Both

Primary aldosteronism

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 goal

-

Sept. 01, 2016