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Completed

NCT Number: NCT02848170

Study of CS-3150 Compared to Olmesartan 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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CS-3150

Drug

CS-3150 2.5mg, oral

olmesartan medoxomil

Drug

olmesartan medoxomil 10 mg, oral

Other names: Benicar

Primary outcomes

  1. Change from baseline in 24 hr blood pressure

    Time frame: 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 outcomes

  1. Change from baseline in morning, evening, and night blood pressure.

    Time frame: 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.

  2. Change from baseline in sitting blood pressure

    Time frame: baseline to week 12

    Relationship between the change from baseline in sitting blood pressure (systolic, diastolic, and average blood pressure) and baseline factors.

  3. Time course of 24 hr blood pressure and sitting blood pressure

    Time frame: week 12

    Time course of 24 hr blood pressure and sitting blood pressure (systolic, diastolic, and average blood pressure)

  4. Proportion of patients achieving 24 hr and sitting blood pressure control

    Time frame: week 12

    Proportion of patients achieving 24 hr and sitting blood pressure control

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 28, 2016
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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