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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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