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NCT02448628 Clinical Trial

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

Hypertension Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02448628
Other study ID # CS3150-A-J206
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 2015
Est. completion date December 2015

Study information
Verified date October 2019
Source Daiichi Sankyo, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CS-3150

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Daiichi Sankyo, Inc.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in sitting systolic and diastolic blood pressure Baseline to end of Week 12
Secondary Change from baseline in UACR Urine Albumin Creatinine Ratio (UACR) Baseline to end of Week 12
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