NCT02807974

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

December 21, 2018

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

June 17, 2016

Last Update Submit

December 19, 2018

Conditions

Hypertension

Keywords

Hypertension with Type 2 Diabetes and AlbuminuriaDiabetic nephropathyDiabetic renal diseaseAlbuminuriaMineralocorticoid receptor antagonist

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Time course of systolic and diastolic blood pressure

    Baseline to end of Week 12

  • Proportion of patients achieving blood pressure control

    Baseline to end of Week 12

  • Change rate from baseline in urine-albumin-to-creatinine ratio

    Baseline to end of Week 12

  • Time course of urine-albumin-to-creatinine ratio

    Baseline to end of Week 12

Study Arms (1)

CS-3150

EXPERIMENTAL

CS-3150 1.25 to 2.5, 5mg, orally, once daily after breakfast for 12 weeks

Drug: CS-3150

Interventions

CS-3150DRUG

CS-3150 1.25 to 2.5, 5mg, orally

CS-3150

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Sanuki-shi, Kagawa-ken, Japan

Location

MeSH Terms

Conditions

HypertensionAlbuminuriaDiabetic Nephropathies

Interventions

esaxerenone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesProteinuriaUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsKidney DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2016

First Posted

June 21, 2016

Study Start

June 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

December 21, 2018

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

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/

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.
More information

Locations

JP(1)