Study of CS-3150 in Combination With ARB or ACE Inhibitor in Hypertensive Patients With Moderate Renal Impairment

NCT02807987 | Completed Phase 3

• 1 other identifier: CS3150-A-J305
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

To examine antihypertensive effect and safety of administration of CS-3150 in combination with ARB or ACE inhibitor in hypertensive patients with moderate renal impairment.

Conditions

Hypertension With Moderate Renal Impairment

Keywords

Mineralocorticoid receptor antagonist; Moderate renal impairment; Hypertension

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 (2)

• 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

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-3150 DRUG

CS-3150 1.25 to 2.5, 5mg, orally

CS-3150

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects aged 20 or order to 80 or younger years at informed consent
• 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/1.73 m2 and \< 60 mL/min/1.73 m2

You may not qualify if:

• Secondary hypertension or malignant hypertension
• Diabetes mellitus with albuminuria
• Subjects under Insulin treatment
• Subjects under or pre-planned for hemodialysis
• Serum potassium level \< 3.5 or ≥ 4.8 mEq/L

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Nagano, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

esaxerenone

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Global Clinical Leader

  Daiichi Sankyo Co., Ltd.

  STUDY DIRECTOR

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: May 15, 2017
• Study Completion: May 15, 2017
• Last Updated: December 21, 2018

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

JP (1)