Essential HypertensionPhase 2NCT02345044
A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Subjects
A Phase 2 study testing CS-3150 and eplerenone in people with Essential Hypertension, run by Daiichi Sankyo at 1 site in Japan.
Trial summary
This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese hypertensive subjects. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- CS-3150 and eplerenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 426 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2015to Oct 2015
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 20 years or older at informed consent
- Subjects with essential hypertension (Sitting SBP ≥ 140 mmHg and < 180 mmHg, Sitting DBP ≥ 90 mmHg and < 110 mmHg,and 24h-hr blood pressure more than 130 mmHg in SBP and 80 mmHg in DBP)
Who cannot join
- Secondary hypertension or malignant hypertension
- Diabetes mellitus with albuminuria
- Serum potassium level < 3.5 or ≥ 5.1 mEq/L
- Reversed day-night life cycle including overnight workers
- eGFR < 60 mL/min/1.73 m^2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Subjects With Hypertension
This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese hypertensive subjects. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.
- Conditions
- Essential Hypertension
- Being tested
- CS-3150, placebo, eplerenone
- Keywords
- Essential hypertension, mineralocorticoid receptor antagonist, CS-3150, Japanese
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS-3150Drug
placeboDrug
eplerenoneDrug
| Study group | Role | What they receive |
|---|---|---|
| CS-3150 1.25 mg | Experimental | One CS-3150 1.25 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast. Receives: Drug: CS-3150; Drug: placebo |
| CS-3150 2.5 mg | Experimental | Two CS-3150 1.25 mg tablets administered orally, once daily after breakfast. Receives: Drug: CS-3150 |
| CS-3150 5 mg | Experimental | Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast. Receives: Drug: CS-3150 |
| Placebo | Placebo comparator | Two placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast. Receives: Drug: placebo |
| Eplerenone, 50-100 mg (Open Label) | Active comparator | One or two 50mg eplerenone tablet(s) administered orally, once daily after breakfast. Receives: Drug: eplerenone |
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
Measured: baseline to end week 12
Secondary outcomes (1)
Change from baseline in 24-hr blood pressure (ABPM)
Measured: Baseline to end week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345044
- Sponsor's protocol ID
- CS3150-A-J203
- Status last verified
- Oct 2019
- First submitted
- 19 Jan 2015
- Last updated
- 8 Oct 2019
- 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/
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Subjects With Hypertension
- ClinicalTrials.gov ID
- NCT02345044
- Acronym / sponsor ID
- CS3150-A-J203
- Conditions
- Essential Hypertension
- Keywords
- Essential hypertension, mineralocorticoid receptor antagonist, CS-3150, Japanese
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 26 Jan 2015 (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.
This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese hypertensive subjects. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CS-3150 1.25 mg | Experimental | Drug: CS-3150, Drug: placeboOne CS-3150 1.25 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast. |
| CS-3150 2.5 mg | Experimental | Drug: CS-3150Two CS-3150 1.25 mg tablets administered orally, once daily after breakfast. |
| CS-3150 5 mg | Experimental | Drug: CS-3150Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast. |
| Placebo | Placebo comparator | Drug: placeboTwo placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast. |
| Eplerenone, 50-100 mg (Open Label) | Active comparator | Drug: eplerenoneOne or two 50mg eplerenone tablet(s) administered orally, once daily after breakfast. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female subjects aged 20 years or older at informed consent
- Subjects with essential hypertension (Sitting SBP ≥ 140 mmHg and < 180 mmHg, Sitting DBP ≥ 90 mmHg and < 110 mmHg,and 24h-hr blood pressure more than 130 mmHg in SBP and 80 mmHg in DBP)
Key exclusion criteria (5 listed)
- Secondary hypertension or malignant hypertension
- Diabetes mellitus with albuminuria
- Serum potassium level < 3.5 or ≥ 5.1 mEq/L
- Reversed day-night life cycle including overnight workers
- eGFR < 60 mL/min/1.73 m^2
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-3150 | Drug | CS-3150 1.25 mg, CS-3150 2.5 mg, CS-3150 5 mg |
| placebo | Drug | CS-3150 1.25 mg, Placebo |
| eplerenone | Drug | Eplerenone, 50-100 mg (Open Label) |
Primary outcome
Change from baseline in sitting systolic and diastolic blood pressure
Time frame: baseline to end week 12
1 secondary outcome
Change from baseline in 24-hr blood pressure (ABPM)
Time frame: Baseline to end 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 8 Oct 2019.
- 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 Essential Hypertension
Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational 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 2 study testing CS-3150 and eplerenone in people with Essential Hypertension, run by Daiichi Sankyo 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 2 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 8 Oct 2019. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2019.