HypertensionPhase 3NCT02807974

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

A Phase 3 study testing CS-3150 in people with Hypertension, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Hypertension
What is being tested?: CS-3150
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteJapan
Study dates: Jun 2016to Mar 2017
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Japan1 site

Study site
Sanuki-shi, Kagawa-ken

Other trials in Japan

About this study

Official title: A Study of CS-3150 to Evaluate Efficacy and Safety 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.

Conditions: Hypertension
Being tested: CS-3150
Keywords: Hypertension with Type 2 Diabetes and Albuminuria, Diabetic nephropathy, Diabetic renal disease, Albuminuria, Mineralocorticoid receptor antagonist
Medical subject headings: Hypertension, Albuminuria, Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CS-3150Drug
CS-3150 1.25 to 2.5, 5mg, orally

Study groups in NCT02807974
Study group	Role	What they receive
CS-3150	Experimental	CS-3150 1.25 to 2.5, 5mg, orally, once daily after breakfast for 12 weeks Receives: Drug: CS-3150

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in sitting systolic and diastolic blood pressure
Change from baseline in sitting systolic and diastolic blood pressure
Measured: Baseline to end of Week 12

Secondary outcomes (4)

Time course of systolic and diastolic blood pressure
Time course of systolic and diastolic blood pressure
Measured: Baseline to end of Week 12
Proportion of patients achieving blood pressure control
Proportion of patients achieving blood pressure control
Measured: Baseline to end of Week 12
Change rate from baseline in urine-albumin-to-creatinine ratio
Change rate from baseline in urine-albumin-to-creatinine ratio.
Measured: Baseline to end of Week 12
Time course of urine-albumin-to-creatinine ratio
Time course of urine-albumin-to-creatinine ratio.
Measured: Baseline to end of Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Mar 2017

First posted21 Jun 2016 (estimated)
Study startJun 2016
Primary completionMar 2017
Study completionMar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02807974
Sponsor's protocol ID: CS3150-A-J306
Status last verified: Mar 2017
First submitted: 17 Jun 2016
Last updated: 21 Dec 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of CS-3150 to Evaluate Efficacy and Safety in Hypertensive Patients With Type 2 Diabetes and Albuminuria.
ClinicalTrials.gov ID: NCT02807974
Acronym / sponsor ID: CS3150-A-J306
Conditions: Hypertension
Keywords: Hypertension with Type 2 Diabetes and Albuminuria, Diabetic nephropathy, Diabetic renal disease, Albuminuria, Mineralocorticoid receptor antagonist
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jun 2016 (actual)
Primary completion: Mar 2017 (actual)
Study completion: Mar 2017 (actual)
First posted: 21 Jun 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CS-3150	Experimental	Drug: CS-3150CS-3150 1.25 to 2.5, 5mg, orally, once daily after breakfast for 12 weeks

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CS-3150CS-3150 1.25 to 2.5, 5mg, orally	Drug	CS-3150

Primary outcome

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

4 secondary outcomes

Time course of systolic and diastolic blood pressure
Time frame: Baseline to end of Week 12
Proportion of patients achieving blood pressure control
Time frame: Baseline to end of Week 12
Change rate from baseline in urine-albumin-to-creatinine ratio
Time frame: Baseline to end of Week 12
Time course of urine-albumin-to-creatinine ratio
Time frame: Baseline to end of Week 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CS-3150 in people with Hypertension, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in sitting systolic and diastolic blood pressure (time frame: Baseline to end of Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02807974.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2018.