MedDataX Logo

Study of CS-3150 in Hypertensive Patients With Type 2 Diabetes and Albuminuria

NCT ID: NCT02807974

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Hypertension with Type 2 Diabetes and Albuminuria Diabetic nephropathy Diabetic renal disease Albuminuria Mineralocorticoid receptor antagonist

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CS-3150

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

Group Type EXPERIMENTAL

CS-3150

Intervention Type DRUG

CS-3150 1.25 to 2.5, 5mg, orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CS-3150

CS-3150 1.25 to 2.5, 5mg, orally

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sanuki-shi, Kagawa-ken, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CS3150-A-J306

Identifier Type: -

Identifier Source: org_study_id