Study of CS-3150 in Hypertensive Patients With Type 2 Diabetes and Albuminuria

A Study of CS-3150 to Evaluate Efficacy and Safety in Hypertensive Patients With Type 2 Diabetes and Albuminuria.

To examine antihypertensive effect and safety of administration of CS-3150 in combination with ARB or ACE inhibitor in hypertensive patients with type 2 diabetes and albuminuria.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: CS-3150

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Kagawa
    • Sanuki-shi, Kagawa, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female subjects aged 20 to 80 years at informed consent
• Subjects with type 2 diabetes and albuminuria (urine albumin-to-creatinine ratio ≥ 30, < 1000 mg/g/Cr)
• Subjects with hypertension (Sitting SBP ≥ 140 mmHg, <180 mmHg and Sitting DBP ≥ 80 mmHg, <110 mmHg
• Treatment with an ARB or ACE inhibitor
• eGFR ≥ 30 mL/min/1.73m^2

Exclusion Criteria:

• Secondary hypertension or malignant hypertension
• Type 1 diabetes
• Secondary glucose intolerance
• Diagnosed with non-diabetic nephropathy
• Serum potassium level < 3.5 or ≥ 4.8 mEq/L

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CS-3150; CS-3150 1.25 to 2.5, 5mg, orally, once daily after breakfast for 12 weeks	Drug: CS-3150; CS-3150 1.25 to 2.5, 5mg, orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in sitting systolic and diastolic blood pressure	Change from baseline in sitting systolic and diastolic blood pressure	Baseline to end of Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time course of systolic and diastolic blood pressure	Time course of systolic and diastolic blood pressure	Baseline to end of Week 12
Proportion of patients achieving blood pressure control	Proportion of patients achieving blood pressure control	Baseline to end of Week 12
Change rate from baseline in urine-albumin-to-creatinine ratio	Change rate from baseline in urine-albumin-to-creatinine ratio.	Baseline to end of Week 12
Time course of urine-albumin-to-creatinine ratio	Time course of urine-albumin-to-creatinine ratio.	Baseline to end of Week 12

Collaborators and Investigators

• Sponsor: Daiichi Sankyo Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 17, 2016
• First Submitted That Met QC Criteria: June 17, 2016
• First Posted (Estimate): June 21, 2016

Study Record Updates

• Last Update Posted (Actual): December 21, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Albuminuria; Diabetic nephropathy; Mineralocorticoid receptor antagonist; Hypertension with Type 2 Diabetes and Albuminuria; Diabetic renal disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Urologic Diseases; Urological Manifestations; Endocrine System Diseases; Diabetes Mellitus; Urination Disorders; Proteinuria; Hypertension; Diabetes Mellitus, Type 2; Albuminuria
• Other Study ID Numbers: CS3150-A-J306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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/
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code