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

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

Phase 3 study to examine the relation between antihypertensive effect and baseline factors exploratively, compared to olmesartan medoxomil in patients with essential hypertension.

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: CS-3150; Drug: olmesartan medoxomil

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CS-3150; CS-3150 2.5 to 5mg, orally, once daily after breakfast for 12 weeks	Drug: CS-3150; CS-3150 2.5mg, oral
Active Comparator: olmesartan medoxomil; olmesartan medoxomil 10 to 20 mg, orally, once daily after breakfast for 12 weeks	Drug: olmesartan medoxomil; olmesartan medoxomil 10 mg, oral; Other Names: Benicar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline to end of Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline to week 12
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.	baseline to week 12
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)	week 12
Proportion of patients achieving 24 hr and sitting blood pressure control	Proportion of patients achieving 24 hr and sitting blood pressure control	week 12

Collaborators and Investigators

• Sponsor: Daiichi Sankyo Co., Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: July 26, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 28, 2016

Study Record Updates

• Last Update Posted (Actual): December 21, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: essential hypertension; mineralocorticoid receptor antagonist; Developmental Phase III
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Olmesartan; Olmesartan Medoxomil
• Other Study ID Numbers: CS3150-A-J303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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 Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code