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Study of CS-3150 in Patients With Essential Hypertension (ESAX-HTN)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2016 by Daiichi Sankyo Inc.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT02890173
First received: August 29, 2016
Last updated: August 31, 2016
Last verified: August 2016
  Purpose
To evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone in patients with essential hypertension.

Condition Intervention Phase
Essential Hypertension
Drug: CS-3150
Drug: Eplerenone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Study of CS-3150 to Evaluate Efficacy and Safety Compared to Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study)

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Change from baseline in sitting blood pressure [ Time Frame: Baseline to end of Week 12 ] [ Designated as safety issue: No ]
    Change from baseline in sitting systolic (SBP) and diastolic blood pressure (DBP).


Secondary Outcome Measures:
  • Change from baseline in 24 hour average blood pressure [ Time Frame: Baseline to end of Week 12 ] [ Designated as safety issue: No ]
    Change from baseline in 24 hour average systolic and diastolic blood pressure.


Estimated Enrollment: 930
Study Start Date: September 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CS-3150 2.5 mg
CS-3150 2.5 mg, orally, once daily after breakfast for 12 weeks
Drug: CS-3150
Experimental: CS-3150 5.0 mg
CS-3150 5 mg, orally, once daily after breakfast for 12 weeks
Drug: CS-3150
Active Comparator: Eplerenone
Eplerenone 50 mg, orally, once daily after breakfast for 12 weeks
Drug: Eplerenone
Other Name: Inspra

Detailed Description:

Primary objective is to evaluate antihypertensive effect and safety of CS-3150 2.5 mg compared to Eplerenone in patients with essential hypertension.

Secondary objective is to evaluate antihypertensive effect and safety of CS-3150 5.0 mg compared to 2.5 mg.

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects aged 20 years or older at informed consent
  • Subjects with essential hypertension satisfying the following blood pressure criteria;

    • Sitting SBP: ≥ 140 mmHg and < 180 mmHg
    • Sitting DBP: ≥ 90 mmHg and < 110 mmHg
    • Mean 24 hr BP: SBP ≥ 130 and DBP ≥ 80 mmHg

Exclusion Criteria:

  • Secondary hypertension or malignant hypertension
  • Diabetic nephropathy or diabetes mellitus with albuminuria
  • Serum potassium level < 3.5 or ≥ 5.1 mEq/L
  • Reversed day-night life cycle including overnight workers
  • eGFR < 60 mL/min/1.73 m^2
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02890173

Contacts
Contact: Satoru Yamakawa +81-3-3492-3131

Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
  More Information

Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02890173     History of Changes
Other Study ID Numbers: CS3150-A-J301 
Study First Received: August 29, 2016
Last Updated: August 31, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Daiichi Sankyo Inc.:
Essential hypertension
Mineralocorticoid receptor antagonist
Esaxerenone
Ambulatory blood pressure monitoring

Additional relevant MeSH terms:
Eplerenone
Hypertension
Vascular Diseases
Cardiovascular Diseases
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents

ClinicalTrials.gov processed this record on September 23, 2016