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

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848170
• Other study ID #: CS3150-A-J303
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• CS-3150
CS-3150 2.5mg, oral
• olmesartan medoxomil
olmesartan medoxomil 10 mg, oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Proportion of patients achieving 24 hr and sitting blood pressure control	Proportion of patients achieving 24 hr and sitting blood pressure control	week 12