A Phase 2 Exploratory Study of CS-3150 in Japanese Hypertensive Patients With Moderate Renal Impairment

NCT02448628 | Completed Phase 2

• 1 other identifier: CS3150-A-J206
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multi-center, open label, dose titration, exploratory study to evaluate efficacy and safety of CS-3150 in Japanese hypertensive patients with moderate renal impairment. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.

Conditions

Hypertension

Keywords

Hypertension; moderate renal impairment; mineralocorticoid receptor antagonist; CS-3150; Japanese

Outcome Measures

Primary Outcomes (1)

• Change from baseline in sitting systolic and diastolic blood pressure

  Baseline to end of Week 12

Secondary Outcomes (1)

• Change from baseline in UACR

  Baseline to end of Week 12

Study Arms (1)

CS-3150

EXPERIMENTAL

CS-3150 1.25 to 5.0 mg , orally, once daily after breakfast for 12 weeks

Drug: CS-3150

Interventions

CS-3150 DRUG

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:

• Men and women Aged 20 years or older and 80 years or younger at informed consent
• Subjects with hypertension (Sitting systolic blood pressure SBP \>= 140 mmHg and \< 180 mmHg, Sitting diastolic blood pressure DBP \>= 80 mmHg and \< 110 mmHg)
• estimated glomerular filtration rate 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
• Serum potassium level \< 3.5 or \>= 5.1 mEq/L
• Subjects under Insulin treatment
• Subjects under or pre-planned for hemodialysis

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (1)

Unknown Facility

Osaka, 530-0001, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

esaxerenone

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: May 19, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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)