Essential HypertensionPhase 3NCT02722265
Long-term Study of CS-3150 as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension
A Phase 3 study testing CS-3150 in people with Essential Hypertension, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
Trial summary
To examine antihypertensive effect, pharmacodynamics, and safety of long-term administration of CS-3150 as monotherapy and in combination with calcium channel blocker or renin-angiotensin system inhibitor in patients with essential hypertension. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2016to 8 Jul 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 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, who do not receive any antihypertensive drugs or receive calcium channel blocker, angiotensin converting enzyme ACE inhibitor, or angiotensin-II receptor blockade ARB during run-in period (Sitting systolic blood pressure SBP ≥ 140 mmHg and < 180 mmHg, Sitting diastolic blood pressure DBP ≥ 90 mmHg and < 110 mmHg, and mean 24hr SBP ≥ 130 and DBP ≥ 80 mmHg)
Who cannot join
- Secondary hypertension or malignant hypertension
- Diabetes mellitus with albuminuria
- Serum potassium level < 3.5 or ≥ 5.1 mEq/L (≥ 4.8 mEq/L if receive ACE inhibitor, or ARB)
- Reversed day-night life cycle including overnight workers
- estimated glomerular filtration rate eGFR < 60 mL/min/1.73 m^2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Multicenter, Interventional, Dose Titration Study to Assess the Long-term Study of CS-3150 2.5mg and 5mg Alone as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension
To examine antihypertensive effect, pharmacodynamics, and safety of long-term administration of CS-3150 as monotherapy and in combination with calcium channel blocker or renin-angiotensin system inhibitor in patients with essential hypertension.
- Conditions
- Essential Hypertension
- Being tested
- CS-3150
- Keywords
- Essential hypertension, Long-term treatment, Mineralocorticoid receptor antagonist
- 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
CS-3150 2.5mg to 5mg, orally, once daily for 28 or 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| CS-3150 | Experimental | CS-3150 2.5mg to 5mg, orally, once daily for 28 or 52 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
Measured: week 0 (baseline) to end of weeks 12, 28, and 52
Secondary outcomes (1)
Change from baseline in 24-hr ambulatory blood pressure monitoring (ABPM)
Measured: week 0 (baseline) to end of weeks 12, 28, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion8 Jul 2017
- Study completion8 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential 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
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722265
- Sponsor's protocol ID
- CS3150-A-J302
- Status last verified
- Oct 2019
- First submitted
- 23 Mar 2016
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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/
Publications
Ichikawa S, Tsutsumi J, Sugimoto K, Yamakawa S. Antihypertensive Effect of Long-Term Monotherapy with Esaxerenone in Patients with Essential Hypertension: Relationship Between Baseline Urinary Sodium Excretion and Its Antihypertensive Effect. Adv Ther. 2022 Oct;39(10):4779-4791. doi: 10.1007/s12325-022-02282-3. Epub 2022 Aug 17.
PubMed 35976603
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
- Open-label, Multicenter, Interventional, Dose Titration Study to Assess the Long-term Study of CS-3150 2.5mg and 5mg Alone as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT02722265
- Acronym / sponsor ID
- CS3150-A-J302
- Conditions
- Essential Hypertension
- Keywords
- Essential hypertension, Long-term treatment, Mineralocorticoid receptor antagonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- 8 Jul 2017 (actual)
- Study completion
- 8 Jul 2017 (actual)
- First posted
- 29 Mar 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, pharmacodynamics, and safety of long-term administration of CS-3150 as monotherapy and in combination with calcium channel blocker or renin-angiotensin system inhibitor in patients with essential hypertension.
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 2.5mg to 5mg, orally, once daily for 28 or 52 weeks |
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, who do not receive any antihypertensive drugs or receive calcium channel blocker, angiotensin converting enzyme ACE inhibitor, or angiotensin-II receptor blockade ARB during run-in period (Sitting systolic blood pressure SBP ≥ 140 mmHg and < 180 mmHg, Sitting diastolic blood pressure DBP ≥ 90 mmHg and < 110 mmHg, and mean 24hr SBP ≥ 130 and DBP ≥ 80 mmHg)
Key exclusion criteria (5 listed)
- Secondary hypertension or malignant hypertension
- Diabetes mellitus with albuminuria
- Serum potassium level < 3.5 or ≥ 5.1 mEq/L (≥ 4.8 mEq/L if receive ACE inhibitor, or ARB)
- Reversed day-night life cycle including overnight workers
- estimated glomerular filtration rate 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-3150CS-3150 2.5mg to 5mg, orally, once daily for 28 or 52 weeks | Drug | CS-3150 |
Primary outcome
change from baseline in sitting systolic and diastolic blood pressure
Time frame: week 0 (baseline) to end of weeks 12, 28, and 52
1 secondary outcome
Change from baseline in 24-hr ambulatory blood pressure monitoring (ABPM)
Time frame: week 0 (baseline) to end of weeks 12, 28, and 52
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.
- Derived from this study: PubMed 35976603Ichikawa S, Tsutsumi J, Sugimoto K, Yamakawa S. Antihypertensive Effect of Long-Term Monotherapy with Esaxerenone in Patients with Essential Hypertension: Relationship Between Baseline Urinary Sodium Excretion and Its Antihypertensive Effect. Adv Ther. 2022 Oct;39(10):4779-4791. doi: 10.1007/s12325-022-02282-3. Epub 2022 Aug 17.
- 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/
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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.
Global Clinical Leader study director
Daiichi Sankyo Co., Ltd.
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 Essential 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 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. 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: week 0 (baseline) to end of weeks 12, 28, and 52). 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 NCT02722265, which also lists 1 linked publication.
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.