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Study of CS-3150 Compared to Olmesartan in Patients With Essential Hypertension

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
CS-3150
olmesartan medoxomil
Sponsored by
Daiichi Sankyo Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring essential hypertension, mineralocorticoid receptor antagonist, Developmental Phase III

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female subjects aged 20 years or older at informed consent
  • Subjects with essential hypertension during run-in period (mean 24 hour systolic blood pressure SBP ≥ 130 and diastolic blood pressure DBP ≥ 80 mmHg and Sitting systolic blood pressure (SBP) ≥ 140 mmHg and < 180 mmHg, Sitting diastolic blood pressure (DBP) ≥ 90 mmHg and < 110 mmHg)

Exclusion Criteria:

  • Secondary hypertension or malignant hypertension
  • Diabetes mellitus with albuminuria
  • Serum potassium level < 3.5 or ≥ 5.1 milliequivalent (mEq)/L
  • 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 2

Arm Type

Experimental

Active Comparator

Arm Label

CS-3150

olmesartan medoxomil

Arm Description

CS-3150 2.5 to 5mg, orally, once daily after breakfast for 12 weeks

olmesartan medoxomil 10 to 20 mg, orally, once daily after breakfast for 12 weeks

Outcomes

Primary Outcome Measures

Change from baseline in 24 hr blood pressure
Relationship between the change from baseline in 24 hr blood pressure (systolic, diastolic, and average blood pressure) and baseline factors frpm baseline to end of Week 12

Secondary Outcome Measures

Change from baseline in morning, evening, and night blood pressure.
Relationship between the change from baseline in morning, evening, and night blood pressure (systolic, diastolic, and average blood pressure) and baseline factors.
Change from baseline in sitting blood pressure
Relationship between the change from baseline in sitting blood pressure (systolic, diastolic, and average blood pressure) and baseline factors.
Time course of 24 hr blood pressure and sitting blood pressure
Time course of 24 hr blood pressure and sitting blood pressure (systolic, diastolic, and average blood pressure)
Proportion of patients achieving 24 hr and sitting blood pressure control
Proportion of patients achieving 24 hr and sitting blood pressure control

Full Information

First Posted
July 26, 2016
Last Updated
December 19, 2018
Sponsor
Daiichi Sankyo Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02848170
Brief Title
Study of CS-3150 Compared to Olmesartan in Patients With Essential Hypertension
Official Title
An Exploratory Study of CS-3150 to Evaluate the Relation Between Antihypertensive Effect and Baseline Factors Compared to Olmesartan Medoxomil in Patients With Essential Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Phase 3 study to examine the relation between antihypertensive effect and baseline factors exploratively, compared to olmesartan medoxomil 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, mineralocorticoid receptor antagonist, Developmental Phase III

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CS-3150
Arm Type
Experimental
Arm Description
CS-3150 2.5 to 5mg, orally, once daily after breakfast for 12 weeks
Arm Title
olmesartan medoxomil
Arm Type
Active Comparator
Arm Description
olmesartan medoxomil 10 to 20 mg, orally, once daily after breakfast for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CS-3150
Intervention Description
CS-3150 2.5mg, oral
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil
Other Intervention Name(s)
Benicar
Intervention Description
olmesartan medoxomil 10 mg, oral
Primary Outcome Measure Information:
Title
Change from baseline in 24 hr blood pressure
Description
Relationship between the change from baseline in 24 hr blood pressure (systolic, diastolic, and average blood pressure) and baseline factors frpm baseline to end of Week 12
Time Frame
baseline to end of Week 12
Secondary Outcome Measure Information:
Title
Change from baseline in morning, evening, and night blood pressure.
Description
Relationship between the change from baseline in morning, evening, and night blood pressure (systolic, diastolic, and average blood pressure) and baseline factors.
Time Frame
baseline to week 12
Title
Change from baseline in sitting blood pressure
Description
Relationship between the change from baseline in sitting blood pressure (systolic, diastolic, and average blood pressure) and baseline factors.
Time Frame
baseline to week 12
Title
Time course of 24 hr blood pressure and sitting blood pressure
Description
Time course of 24 hr blood pressure and sitting blood pressure (systolic, diastolic, and average blood pressure)
Time Frame
week 12
Title
Proportion of patients achieving 24 hr and sitting blood pressure control
Description
Proportion of patients achieving 24 hr and sitting blood pressure control
Time Frame
week 12

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 during run-in period (mean 24 hour systolic blood pressure SBP ≥ 130 and diastolic blood pressure DBP ≥ 80 mmHg and Sitting systolic blood pressure (SBP) ≥ 140 mmHg and < 180 mmHg, Sitting diastolic blood pressure (DBP) ≥ 90 mmHg and < 110 mmHg) Exclusion Criteria: Secondary hypertension or malignant hypertension Diabetes mellitus with albuminuria Serum potassium level < 3.5 or ≥ 5.1 milliequivalent (mEq)/L 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, Inc.
Official's Role
Study Director
Facility Information:
City
Tokyo
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/

Learn more about this trial

Study of CS-3150 Compared to Olmesartan in Patients With Essential Hypertension

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