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

Not Applicable

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: CS-3150; Drug: olmesartan medoxomil

• Registration Number: NCT02848170
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-28
• Study Start: 2016-08
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-05
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CS-3150	CS-3150	CS-3150 2.5 to 5mg, orally, once daily after breakfast for 12 weeks
olmesartan medoxomil	olmesartan medoxomil	olmesartan medoxomil 10 to 20 mg, orally, once daily after breakfast for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in 24 hr blood pressure	baseline to end of Week 12	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

Name	Time	Method
Change from baseline in morning, evening, and night blood pressure.	baseline to week 12	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	baseline to week 12	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	week 12	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	week 12	Proportion of patients achieving 24 hr and sitting blood pressure control