Essential HypertensionPhase 3ESAX-HTNNCT02890173
Study of CS-3150 in Patients With Essential Hypertension
A Phase 3 study testing CS-3150 and Eplerenone in people with Essential Hypertension, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
Trial summary
To evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone 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 and Eplerenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,001 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2016to 11 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 satisfying the following blood pressure criteria;
- Sitting SBP: ≥ 140 mmHg and < 180 mmHg
- Sitting DBP: ≥ 90 mmHg and < 110 mmHg
- Mean 24 hr BP: SBP ≥ 130 and DBP ≥ 80 mmHg
Who cannot join
- Secondary hypertension or malignant hypertension
- Diabetic nephropathy or 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 Double Blind Study of CS-3150 to Evaluate Efficacy and Safety Compared to Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study)
To evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone in patients with essential hypertension.
Read the detailed description
Primary objective is to evaluate antihypertensive effect and safety of CS-3150 2.5 mg compared to Eplerenone in patients with essential hypertension.
Secondary objective is to evaluate antihypertensive effect and safety of CS-3150 5.0 mg compared to 2.5 mg.
- Conditions
- Essential Hypertension
- Being tested
- CS-3150, Eplerenone
- Keywords
- Essential hypertension, Mineralocorticoid receptor antagonist, Esaxerenone, Ambulatory blood pressure monitoring
- 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
EplerenoneDrug
Also called Inspra
| Study group | Role | What they receive |
|---|---|---|
| CS-3150 2.5 mg | Experimental | CS-3150 2.5 mg, orally, once daily after breakfast for 12 weeks Receives: Drug: CS-3150 |
| CS-3150 5.0 mg | Experimental | CS-3150 5 mg, orally, once daily after breakfast for 12 weeks Receives: Drug: CS-3150 |
| Eplerenone | Active comparator | Eplerenone 50 mg, orally, once daily after breakfast for 12 weeks 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 blood pressure
Change from baseline in sitting systolic (SBP) and diastolic blood pressure (DBP).
Measured: Baseline to end of Week 12
Secondary outcomes (1)
Change from baseline in 24 hour average blood pressure
Change from baseline in 24 hour average systolic and diastolic blood pressure.
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.
- First posted7 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion11 Jul 2017
- Study completion11 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,001 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
- NCT02890173
- Sponsor's protocol ID
- CS3150-A-J301
- Acronym
- ESAX-HTN
- Status last verified
- Aug 2017
- First submitted
- 29 Aug 2016
- Last updated
- 21 Dec 2018
- 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
Ito S, Itoh H, Rakugi H, Okuda Y, Yoshimura M, Yamakawa S. Double-Blind Randomized Phase 3 Study Comparing Esaxerenone (CS-3150) and Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study). Hypertension. 2020 Jan;75(1):51-58. doi: 10.1161/HYPERTENSIONAHA.119.13569. Epub 2019 Dec 2.
PubMed 31786983
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 Double Blind Study of CS-3150 to Evaluate Efficacy and Safety Compared to Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study)
- ClinicalTrials.gov ID
- NCT02890173
- Acronym / sponsor ID
- ESAX-HTN / CS3150-A-J301
- Conditions
- Essential Hypertension
- Keywords
- Essential hypertension, Mineralocorticoid receptor antagonist, Esaxerenone, Ambulatory blood pressure monitoring
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,001 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- 11 Jul 2017 (actual)
- Study completion
- 11 Jul 2017 (actual)
- First posted
- 7 Sep 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 evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone in patients with essential hypertension.
Detailed description
Primary objective is to evaluate antihypertensive effect and safety of CS-3150 2.5 mg compared to Eplerenone in patients with essential hypertension.
Secondary objective is to evaluate antihypertensive effect and safety of CS-3150 5.0 mg compared to 2.5 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CS-3150 2.5 mg | Experimental | Drug: CS-3150CS-3150 2.5 mg, orally, once daily after breakfast for 12 weeks |
| CS-3150 5.0 mg | Experimental | Drug: CS-3150CS-3150 5 mg, orally, once daily after breakfast for 12 weeks |
| Eplerenone | Active comparator | Drug: EplerenoneEplerenone 50 mg, orally, once daily after breakfast for 12 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects aged 20 years or older at informed consent
- Subjects with essential hypertension satisfying the following blood pressure criteria;
Key exclusion criteria (5 listed)
- Secondary hypertension or malignant hypertension
- Diabetic nephropathy or 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 2.5 mg, CS-3150 5.0 mg |
| EplerenoneAlso: Inspra | Drug | Eplerenone |
Primary outcome
Change from baseline in sitting blood pressure
Time frame: Baseline to end of Week 12
Change from baseline in sitting systolic (SBP) and diastolic blood pressure (DBP).
1 secondary outcome
Change from baseline in 24 hour average blood pressure
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.
- Derived from this study: PubMed 31786983Ito S, Itoh H, Rakugi H, Okuda Y, Yoshimura M, Yamakawa S. Double-Blind Randomized Phase 3 Study Comparing Esaxerenone (CS-3150) and Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study). Hypertension. 2020 Jan;75(1):51-58. doi: 10.1161/HYPERTENSIONAHA.119.13569. Epub 2019 Dec 2.
- 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 and Eplerenone 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 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 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 NCT02890173, 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 21 Dec 2018.