Back to resultsLong-term Study of CS-3150 as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension
Primary Purpose
Essential Hypertension
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
CS-3150
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension focused on measuring Essential hypertension, Long-term treatment, Mineralocorticoid receptor antagonist
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects aged 20 years or older at informed consent
- Subjects with essential hypertension, who do not receive any antihypertensive drugs or receive calcium channel blocker, angiotensin converting enzyme ACE inhibitor, or angiotensin-II receptor blockade ARB during run-in period (Sitting systolic blood pressure SBP ≥ 140 mmHg and < 180 mmHg, Sitting diastolic blood pressure DBP ≥ 90 mmHg and < 110 mmHg, and mean 24hr SBP ≥ 130 and DBP ≥ 80 mmHg)
Exclusion Criteria:
- Secondary hypertension or malignant hypertension
- Diabetes mellitus with albuminuria
- Serum potassium level < 3.5 or ≥ 5.1 mEq/L (≥ 4.8 mEq/L if receive ACE inhibitor, or ARB)
- Reversed day-night life cycle including overnight workers
- estimated glomerular filtration rate eGFR < 60 mL/min/1.73 m^2.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CS-3150
Arm Description
CS-3150 2.5mg to 5mg, orally, once daily for 28 or 52 weeks
Outcomes
Primary Outcome Measures
change from baseline in sitting systolic and diastolic blood pressure
Secondary Outcome Measures
Change from baseline in 24-hr ambulatory blood pressure monitoring (ABPM)
Full Information
NCT ID
NCT02722265
First Posted
March 23, 2016
Last Updated
October 4, 2019
Sponsor
Daiichi Sankyo Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02722265
Brief Title
Long-term Study of CS-3150 as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension
Official Title
Open-label, Multicenter, Interventional, Dose Titration Study to Assess the Long-term Study of CS-3150 2.5mg and 5mg Alone as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
July 8, 2017 (Actual)
Study Completion Date
July 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To examine antihypertensive effect, pharmacodynamics, and safety of long-term administration of CS-3150 as monotherapy and in combination with calcium channel blocker or renin-angiotensin system inhibitor in patients with essential hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Essential hypertension, Long-term treatment, Mineralocorticoid receptor antagonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
368 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CS-3150
Arm Type
Experimental
Arm Description
CS-3150 2.5mg to 5mg, orally, once daily for 28 or 52 weeks
Intervention Type
Drug
Intervention Name(s)
CS-3150
Intervention Description
CS-3150 2.5mg to 5mg, orally, once daily for 28 or 52 weeks
Primary Outcome Measure Information:
Title
change from baseline in sitting systolic and diastolic blood pressure
Time Frame
week 0 (baseline) to end of weeks 12, 28, and 52
Secondary Outcome Measure Information:
Title
Change from baseline in 24-hr ambulatory blood pressure monitoring (ABPM)
Time Frame
week 0 (baseline) to end of weeks 12, 28, and 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female subjects aged 20 years or older at informed consent
Subjects with essential hypertension, who do not receive any antihypertensive drugs or receive calcium channel blocker, angiotensin converting enzyme ACE inhibitor, or angiotensin-II receptor blockade ARB during run-in period (Sitting systolic blood pressure SBP ≥ 140 mmHg and < 180 mmHg, Sitting diastolic blood pressure DBP ≥ 90 mmHg and < 110 mmHg, and mean 24hr SBP ≥ 130 and DBP ≥ 80 mmHg)
Exclusion Criteria:
Secondary hypertension or malignant hypertension
Diabetes mellitus with albuminuria
Serum potassium level < 3.5 or ≥ 5.1 mEq/L (≥ 4.8 mEq/L if receive ACE inhibitor, or ARB)
Reversed day-night life cycle including overnight workers
estimated glomerular filtration rate eGFR < 60 mL/min/1.73 m^2.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Osaka
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/
Citations:
PubMed Identifier
35976603
Citation
Ichikawa S, Tsutsumi J, Sugimoto K, Yamakawa S. Antihypertensive Effect of Long-Term Monotherapy with Esaxerenone in Patients with Essential Hypertension: Relationship Between Baseline Urinary Sodium Excretion and Its Antihypertensive Effect. Adv Ther. 2022 Oct;39(10):4779-4791. doi: 10.1007/s12325-022-02282-3. Epub 2022 Aug 17.
Results Reference
derived
Learn more about this trial
Long-term Study of CS-3150 as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension
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