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

Daiichi Sankyo

Status: Completed

Conditions: Essential Hypertension

Treatments: Drug: CS-3150; Drug: olmesartan medoxomil

Study type: Interventional

Funder types: Industry

Identifiers

NCT02848170

CS3150-A-J303

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

CS-3150

Experimental group

Description:

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

Treatment:

Drug: CS-3150

olmesartan medoxomil

Active Comparator group

Description:

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

Treatment:

Drug: olmesartan medoxomil