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

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Daiichi Sankyo

Status and phase

Completed
Phase 3

Conditions

Hypertension

Treatments

Drug: CS-3150

Study type

Interventional

Funder types

Industry

Identifiers

NCT02807974
CS3150-A-J306

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

51 participants in 1 patient group

CS-3150
Experimental group
Description:
CS-3150 1.25 to 2.5, 5mg, orally, once daily after breakfast for 12 weeks
Treatment:
Drug: CS-3150

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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