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Completed

NCT Number: NCT02807974

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

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.

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Key information

Conditions

Hypertension Albuminuria Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanuki-shi, Kagawa-ken, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CS-3150

Drug

CS-3150 1.25 to 2.5, 5mg, orally

Primary outcomes

  1. Change from baseline in sitting systolic and diastolic blood pressure

    Time frame: Baseline to end of Week 12

    Change from baseline in sitting systolic and diastolic blood pressure

Secondary outcomes

  1. Time course of systolic and diastolic blood pressure

    Time frame: Baseline to end of Week 12

    Time course of systolic and diastolic blood pressure

  2. Proportion of patients achieving blood pressure control

    Time frame: Baseline to end of Week 12

    Proportion of patients achieving blood pressure control

  3. Change rate from baseline in urine-albumin-to-creatinine ratio

    Time frame: Baseline to end of Week 12

    Change rate from baseline in urine-albumin-to-creatinine ratio.

  4. Time course of urine-albumin-to-creatinine ratio

    Time frame: Baseline to end of Week 12

    Time course of urine-albumin-to-creatinine ratio.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

A Study of CS-3150 to Evaluate Efficacy and Safety in Hypertensive Patients With Type 2 Diabetes and Albuminuria.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 21, 2016
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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