Primary AldosteronismNCT02885662
Study of CS-3150 in Patients With Primary Aldosteronism
A study testing CS-3150 in people with Primary Aldosteronism, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
Trial summary
To examine antihypertensive effect and safety of CS-3150 in patients with primary aldosteronism. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Primary Aldosteronism
- 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
- 44 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2016to 20 Jul 2017
- Phase
- Interventional
- 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
- Patients diagnosed primary aldosteronism by screening test of plasma aldosterone concentration (PAC) and aldosterone to renin ratio (ARR), and confirmatory testing
- Patients satisfying following blood pressure;
- sitting systolic blood pressure (SBP) ≥ 140 mmHg and <180 mmHg
- sitting diastolic blood pressure (DBP) ≥ 90 mmHg and <110 mmHg
Who cannot join
- Secondary hypertension except primary aldosteronism or hypertensive emergency
- Patients diagnosed diabetic nephropathy
- Patients with type 1 diabetes
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
- Serum potassium level < 3.0 or ≥ 5.1 milliequivalent (mEq)/L
Trial locations and contacts
1 site in 1 country.
Japan1 site
Japan Organaization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital
Yokohama, Kanagawa, 222-0036
About this study
Official title: A Study of CS-3150 to Evaluate Efficacy and Safety in Patients With Primary Aldosteronism
To examine antihypertensive effect and safety of CS-3150 in patients with primary aldosteronism.
- Conditions
- Primary Aldosteronism
- Being tested
- CS-3150
- Keywords
- Primary aldosteronism, Hypertension, mineralocorticoid receptor antagonist, Developmental Phase III
- Medical subject headings
- Hyperaldosteronism, 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 5.0 mg , orally.
| Study group | Role | What they receive |
|---|---|---|
| CS-3150 | Experimental | CS-3150 2.5 to 5.0 mg , 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 blood pressure
Change from baseline in sitting systolic and diastolic blood pressure
Measured: Baseline to end of Week 12
Secondary outcomes (2)
Time course of sitting blood pressure
Time course of sitting systolic and diastolic blood pressure
Measured: Baseline to end of Week 12
Proportion of patients achieving sitting blood pressure goal
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 posted31 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion20 Jul 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885662
- Sponsor's protocol ID
- CS3150-A-J307
- Status last verified
- Aug 2017
- First submitted
- 26 Aug 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 of CS-3150 to Evaluate Efficacy and Safety in Patients With Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT02885662
- Acronym / sponsor ID
- CS3150-A-J307
- Conditions
- Primary Aldosteronism
- Keywords
- Primary aldosteronism, Hypertension, mineralocorticoid receptor antagonist, Developmental Phase III
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 31 Aug 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 CS-3150 in patients with primary aldosteronism.
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 5.0 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
- Patients diagnosed primary aldosteronism by screening test of plasma aldosterone concentration (PAC) and aldosterone to renin ratio (ARR), and confirmatory testing
- Patients satisfying following blood pressure;
Key exclusion criteria (5 listed)
- Secondary hypertension except primary aldosteronism or hypertensive emergency
- Patients diagnosed diabetic nephropathy
- Patients with type 1 diabetes
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
- Serum potassium level < 3.0 or ≥ 5.1 milliequivalent (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 2.5 to 5.0 mg , orally. | Drug | CS-3150 |
Primary outcome
Change from baseline in sitting blood pressure
Time frame: Baseline to end of Week 12
Change from baseline in sitting systolic and diastolic blood pressure
2 secondary outcomes
Time course of sitting blood pressure
Time frame: Baseline to end of Week 12
Proportion of patients achieving sitting blood pressure goal
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 Primary Aldosteronism
Not yet recruitingPhase 2
SYH2072 Tablets in Participants With Primary Aldosteronism
Primary Aldosteronism
Recruiting
Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
Hyperaldosteronism; Primary, Primary Aldosteronism Due to Aldosterone Producing Adenoma
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Active, not recruiting
Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA
Primary Aldosteronism
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CS-3150 in people with Primary Aldosteronism, 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.
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?
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.