Study of CS-3150 in Patients With Severe Hypertension

NCT02808026 | Completed Phase 3

• 1 other identifier: CS3150-A-J304
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To examine antihypertensive effect and safety of administration of CS-3150 in patients with severe hypertension (Grade III).

Conditions

Severe Hypertension

Keywords

severe hypertension; grade III hypertension; mineralocorticoid receptor antagonist

Outcome Measures

Primary Outcomes (1)

• Change from baseline in sitting systolic and diastolic blood pressure

  Baseline to end of Week 8

Secondary Outcomes (2)

• Time course of systolic and diastolic blood pressure

  Baseline to end of Week 8

• Proportion of patients achieving blood pressure control

  Baseline to end of Week 8

Study Arms (1)

CS-3150

EXPERIMENTAL

CS-3150 2.5 to 5mg, orally, once daily after breakfast for 8 weeks

Drug: CS-3150

Interventions

CS-3150 DRUG

CS-3150 2.5 to 5mg, orally, once daily after breakfast

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 to 80 years at informed consent
• Subjects with severe hypertension, who do not receive any antihypertensive drugs or receive antihypertensive drug (except for potassium-sparing diuretics) during run-in period (Sitting SBP ≥ 180 mmHg or Sitting DBP ≥ 110 mmHg)

You may not qualify if:

• Patients who are suspected hypertensive emergency
• Secondary hypertension or malignant hypertension
• Diabetes mellitus with albuminuria
• Serum potassium level \< 3.5 or ≥ 5.1 mEq/L (≥ 4.8 mEq/L if receive RA inhibitor)
• eGFR \< 60 mL/min/1.73 m\^2.

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Sapporo, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

esaxerenone

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular 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: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: December 21, 2018

Record last verified: 2017-03

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)