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A Study to Evaluate Efficacy and Safety of CS-3150 in Patients With Severe Hypertension (Grade III)

A Study to Evaluate Efficacy and Safety of CS-3150 in Patients With Severe Hypertension (Grade III)

20

The FAS(20 subjects) were male 85.0%, the mean age 52.7 years, the mean value of sitting blood pressure was 174.4 mmHg in systolic blood pressure and 114.9 mmHg in diastolic blood pressure. Blood pressure classified as systolic blood pressure <180 mmHg or diastolic blood pressure <110 mmHg was 70.0%.

Twenty subjects were registered and received CS-3150. Two of them were withdrawn from the study and 18 completed the study. The reasons for discontinuation were 2 subjects who withdrew consent. All of 20 subjects were included in the FAS and Safety-Analysis Set.

The incidence of adverse events was 45.0% (9/20), and the incidence of adverse events considered related to the study drug was 10.0% (2/20). All adverse events were assessed as mild in severity and resolved with or without treatment. No deaths or serious adverse events were reported.

- Change in sitting blood pressure Point estimates of change in sitting BP (95% CI) were-21.0 (-27.3 to-14.6) for systolic BP and-13.2 (-18.4 to-7.9) 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, both P < 0.0001).

- Change in sitting blood pressure The arithmetic mean (SD) of sitting blood pressure was 174.4 (15.66) mmHg in systolic blood pressure and 114.9 (12.07) mmHg in diastolic blood pressure during the run-in period. The SD and diastolic blood pressure continued to decrease from Week 1 to Week 8 in the treatment period. - Proportion of patients achieving the target of sitting BP reduction Point estimates (95% confidence intervals) of the percentage of subjects achieving the target blood pressure reduction (baseline 2) were 10.0% (1.2% to 31.7%) at the end of treatment when the target blood pressure for sitting blood pressure was set at 140/90 mmHg (baseline 1), when subjects with diabetes mellitus were set at <130/80 mmHg, and when subjects without diabetes mellitus were set at <140/90 mmHg (baseline 2).

The efficacy and safety of CS-3150 titrated from 2.5 mg to 5 mg were investigated in patients with hypertension of grade III after 8 weeks. The change in sitting blood pressure was significantly reduced in both systolic blood pressure and diastolic blood pressure, confirming a clear antihypertensive effect. There were no safety issues.

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. 22, 2016

Interventional

Multi-center, open label, dose titration study

treatment purpose

3

1) Male and female subjects aged 20 to 80 years at informed consent
2) Subjects with hypertension, who do not receive any antihypertensive drugs or receive antihypertensive drugs (except for potassium-sparing diuretics) during run-in period (Sitting SBP >= 180 mmHg or Sitting DBP >= 110 mmHg)

1) Suspected Hypertensive emergency
2) Secondary hypertension or malignant hypertension
3) Diabetic nephropathy
4) Serum potassium level < 3.5 or >= 5.1 mEq/L (< 3.5 or>= 4.8 mEq/L if receive RA inhibitor)
5) eGFR < 60 mL/min/1.73 m^2.

Both

Severe hypertension (Grade III)

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 study drug once daily after breakfast for 8 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

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

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May. 18, 2016