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Study of CS-3150 in Patients With Primary Aldosteronism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02885662
Recruitment Status : Completed
First Posted : August 31, 2016
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Brief Summary:
To examine antihypertensive effect and safety of CS-3150 in patients with primary aldosteronism.

Condition or disease Intervention/treatment Phase
Primary Aldosteronism Drug: CS-3150 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of CS-3150 to Evaluate Efficacy and Safety in Patients With Primary Aldosteronism
Study Start Date : September 2016
Actual Primary Completion Date : July 20, 2017
Actual Study Completion Date : July 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CS-3150
CS-3150 2.5 to 5.0 mg , orally, once daily after breakfast for 12 weeks.
Drug: CS-3150
CS-3150 2.5 to 5.0 mg , orally.




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


Secondary Outcome Measures :
  1. Time course of sitting blood pressure [ Time Frame: Baseline to end of Week 12 ]
    Time course of sitting systolic and diastolic blood pressure

  2. Proportion of patients achieving sitting blood pressure goal [ 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
  • Patients diagnosed primary aldosteronism by screening test of plasma aldosterone concentration (PAC) and aldosterone to renin ratio (ARR), and confirmatory testing
  • Patients satisfying following blood pressure;

    • sitting systolic blood pressure (SBP) ≥ 140 mmHg and <180 mmHg
    • sitting diastolic blood pressure (DBP) ≥ 90 mmHg and <110 mmHg

Exclusion Criteria:

  • Secondary hypertension except primary aldosteronism or hypertensive emergency
  • Patients diagnosed diabetic nephropathy
  • Patients with type 1 diabetes
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
  • Serum potassium level < 3.0 or ≥ 5.1 milliequivalent (mEq)/L

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): NCT02885662


Locations
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Japan
Japan Organaization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital
Yokohama, Kanagawa, Japan, 222-0036
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
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Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02885662    
Other Study ID Numbers: CS3150-A-J307
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: August 2017
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. ( Daiichi Sankyo Co., Ltd. ):
Primary aldosteronism
Hypertension
mineralocorticoid receptor antagonist
Developmental Phase III
Additional relevant MeSH terms:
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Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases