Study of CS-3150 in Patients With Primary Aldosteronism

NCT02885662 | Completed

• 1 other identifier: CS3150-A-J307
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

To examine antihypertensive effect and safety of CS-3150 in patients with primary aldosteronism.

Conditions

Primary Aldosteronism

Keywords

Primary aldosteronism; Hypertension; mineralocorticoid receptor antagonist; Developmental Phase III

Outcome Measures

Primary Outcomes (1)

• Change from baseline in sitting blood pressure

  Change from baseline in sitting systolic and diastolic blood pressure

  Baseline to end of Week 12

Secondary Outcomes (2)

• Time course of sitting blood pressure

  Baseline to end of Week 12

• Proportion of patients achieving sitting blood pressure goal

  Baseline to end of Week 12

Study Arms (1)

CS-3150

EXPERIMENTAL

CS-3150 2.5 to 5.0 mg , orally, once daily after breakfast for 12 weeks.

Drug: CS-3150

Interventions

CS-3150 DRUG

CS-3150 2.5 to 5.0 mg , orally.

CS-3150

Eligibility Criteria

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

You may qualify if:

• Male and female subjects aged 20 years or older at informed consent
• Patients diagnosed primary aldosteronism by screening test of plasma aldosterone concentration (PAC) and aldosterone to renin ratio (ARR), and confirmatory testing
• Patients satisfying following blood pressure;
• sitting systolic blood pressure (SBP) ≥ 140 mmHg and \<180 mmHg
• sitting diastolic blood pressure (DBP) ≥ 90 mmHg and \<110 mmHg

You may not qualify if:

• Secondary hypertension except primary aldosteronism or hypertensive emergency
• Patients diagnosed diabetic nephropathy
• Patients with type 1 diabetes
• Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2
• Serum potassium level \< 3.0 or ≥ 5.1 milliequivalent (mEq)/L

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (1)

Japan Organaization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital

Yokohama, Kanagawa, 222-0036, Japan

Location

MeSH Terms

Conditions

Hyperaldosteronism; Hypertension

Interventions

esaxerenone

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: August 31, 2016
• Study Start: September 1, 2016
• Primary Completion: July 20, 2017
• Study Completion: July 20, 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)