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Trial record 93 of 112 for:    EPLERENONE

A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Subjects

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ClinicalTrials.gov Identifier: NCT02345044
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:
This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese hypertensive subjects. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: CS-3150 Drug: placebo Drug: eplerenone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Subjects With Hypertension
Study Start Date : January 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone

Arm Intervention/treatment
Experimental: CS-3150 1.25 mg
One CS-3150 1.25 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
Drug: CS-3150
Drug: placebo
Experimental: CS-3150 2.5 mg
Two CS-3150 1.25 mg tablets administered orally, once daily after breakfast.
Drug: CS-3150
Experimental: CS-3150 5 mg
Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast.
Drug: CS-3150
Placebo Comparator: Placebo
Two placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast.
Drug: placebo
Active Comparator: Eplerenone, 50-100 mg (Open Label)
One or two 50mg eplerenone tablet(s) administered orally, once daily after breakfast.
Drug: eplerenone



Primary Outcome Measures :
  1. Change from baseline in sitting systolic and diastolic blood pressure [ Time Frame: baseline to end week 12 ]

Secondary Outcome Measures :
  1. Change from baseline in 24-hr blood pressure (ABPM) [ Time Frame: Baseline to end week 12 ]
  2. Change in serum potassium [ Time Frame: Baseline to end of Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects aged 20 years or older at informed consent
  • Subjects with essential hypertension (Sitting SBP ≥ 140 mmHg and < 180 mmHg, Sitting DBP ≥ 90 mmHg and < 110 mmHg,and 24h-hr blood pressure more than 130 mmHg in SBP and 80 mmHg in DBP)

Exclusion Criteria:

  • Secondary hypertension or malignant hypertension
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345044


Locations
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Japan
Osaka, Japan, 530-0001
Sponsors and Collaborators
Daiichi Sankyo, Inc.

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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT02345044     History of Changes
Other Study ID Numbers: CS3150-A-J203
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Keywords provided by Daiichi Sankyo, Inc.:
Essential hypertension
mineralocorticoid receptor antagonist
CS-3150
Japanese
Additional relevant MeSH terms:
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Eplerenone
Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents