Severe HypertensionPhase 3NCT02808026
Study of CS-3150 in Patients With Severe Hypertension
A Phase 3 study testing CS-3150 in people with Severe Hypertension, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
Trial summary
To examine antihypertensive effect and safety of administration of CS-3150 in patients with severe hypertension (Grade III). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Severe 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
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2016to Feb 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 severe hypertension, who do not receive any antihypertensive drugs or receive antihypertensive drug (except for potassium-sparing diuretics) during run-in period (Sitting SBP ≥ 180 mmHg or Sitting DBP ≥ 110 mmHg)
Who cannot join
- Patients who are suspected hypertensive emergency
- 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 RA inhibitor)
- eGFR < 60 mL/min/1.73 m^2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Patients With Severe Hypertension (Grade III)
To examine antihypertensive effect and safety of administration of CS-3150 in patients with severe hypertension (Grade III).
- Conditions
- Severe Hypertension
- Being tested
- CS-3150
- Keywords
- severe hypertension, grade III hypertension, mineralocorticoid receptor antagonist
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS-3150Drug
CS-3150 2.5 to 5mg, orally, once daily after breakfast
| Study group | Role | What they receive |
|---|---|---|
| CS-3150 | Experimental | CS-3150 2.5 to 5mg, orally, once daily after breakfast for 8 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: Baseline to end of Week 8
Secondary outcomes (2)
Time course of systolic and diastolic blood pressure
Measured: Baseline to end of Week 8
Proportion of patients achieving blood pressure control
Measured: Baseline to end of Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808026
- Sponsor's protocol ID
- CS3150-A-J304
- 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/
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 to Evaluate Efficacy and Safety of CS-3150 in Japanese Patients With Severe Hypertension (Grade III)
- ClinicalTrials.gov ID
- NCT02808026
- Acronym / sponsor ID
- CS3150-A-J304
- Conditions
- Severe Hypertension
- Keywords
- severe hypertension, grade III hypertension, mineralocorticoid receptor antagonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 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 patients with severe hypertension (Grade III).
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 2.5 to 5mg, orally, once daily after breakfast for 8 weeks |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female subjects aged 20 to 80 years at informed consent
- Subjects with severe hypertension, who do not receive any antihypertensive drugs or receive antihypertensive drug (except for potassium-sparing diuretics) during run-in period (Sitting SBP ≥ 180 mmHg or Sitting DBP ≥ 110 mmHg)
Key exclusion criteria (5 listed)
- Patients who are suspected hypertensive emergency
- 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 RA inhibitor)
- 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 2.5 to 5mg, orally, once daily after breakfast | Drug | CS-3150 |
Primary outcome
Change from baseline in sitting systolic and diastolic blood pressure
Time frame: Baseline to end of Week 8
2 secondary outcomes
Time course of systolic and diastolic blood pressure
Time frame: Baseline to end of Week 8
Proportion of patients achieving blood pressure control
Time frame: Baseline to end of Week 8
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/
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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.
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 Severe 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 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 8). 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 21 Dec 2018.