Essential HypertensionNCT02848170
Study of CS-3150 Compared to Olmesartan in Patients With Essential Hypertension
A study testing CS-3150 and olmesartan medoxomil in people with Essential Hypertension, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
Trial summary
Phase 3 study to examine the relation between antihypertensive effect and baseline factors exploratively, compared to olmesartan medoxomil 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 olmesartan medoxomil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2016to Apr 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
- Subjects with essential hypertension during run-in period (mean 24 hour systolic blood pressure SBP ≥ 130 and diastolic blood pressure DBP ≥ 80 mmHg and 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 or malignant hypertension
- Diabetes mellitus with albuminuria
- Serum potassium level < 3.5 or ≥ 5.1 milliequivalent (mEq)/L
- 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: An Exploratory Study of CS-3150 to Evaluate the Relation Between Antihypertensive Effect and Baseline Factors Compared to Olmesartan Medoxomil in Patients With Essential Hypertension
Phase 3 study to examine the relation between antihypertensive effect and baseline factors exploratively, compared to olmesartan medoxomil in patients with essential hypertension.
- Conditions
- Essential Hypertension
- Being tested
- CS-3150, olmesartan medoxomil
- Keywords
- essential hypertension, mineralocorticoid receptor antagonist, Developmental Phase III
- 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, oral
olmesartan medoxomilDrug
Also called Benicar
olmesartan medoxomil 10 mg, oral
| Study group | Role | What they receive |
|---|---|---|
| CS-3150 | Experimental | CS-3150 2.5 to 5mg, orally, once daily after breakfast for 12 weeks Receives: Drug: CS-3150 |
| olmesartan medoxomil | Active comparator | olmesartan medoxomil 10 to 20 mg, orally, once daily after breakfast for 12 weeks Receives: Drug: olmesartan medoxomil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in 24 hr blood pressure
Relationship between the change from baseline in 24 hr blood pressure (systolic, diastolic, and average blood pressure) and baseline factors frpm baseline to end of Week 12
Measured: baseline to end of Week 12
Secondary outcomes (4)
Change from baseline in morning, evening, and night blood pressure.
Relationship between the change from baseline in morning, evening, and night blood pressure (systolic, diastolic, and average blood pressure) and baseline factors.
Measured: baseline to week 12
Change from baseline in sitting blood pressure
Relationship between the change from baseline in sitting blood pressure (systolic, diastolic, and average blood pressure) and baseline factors.
Measured: baseline to week 12
Time course of 24 hr blood pressure and sitting blood pressure
Time course of 24 hr blood pressure and sitting blood pressure (systolic, diastolic, and average blood pressure)
Measured: week 12
Proportion of patients achieving 24 hr and sitting blood pressure control
Proportion of patients achieving 24 hr and sitting blood pressure control
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionApr 2017
- Study completionApr 2017
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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT02848170
- Sponsor's protocol ID
- CS3150-A-J303
- Status last verified
- May 2017
- First submitted
- 26 Jul 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
- An Exploratory Study of CS-3150 to Evaluate the Relation Between Antihypertensive Effect and Baseline Factors Compared to Olmesartan Medoxomil in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT02848170
- Acronym / sponsor ID
- CS3150-A-J303
- Conditions
- Essential Hypertension
- Keywords
- essential hypertension, mineralocorticoid receptor antagonist, Developmental Phase III
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 28 Jul 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.
Phase 3 study to examine the relation between antihypertensive effect and baseline factors exploratively, compared to olmesartan medoxomil in patients with essential hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CS-3150 | Experimental | Drug: CS-3150CS-3150 2.5 to 5mg, orally, once daily after breakfast for 12 weeks |
| olmesartan medoxomil | Active comparator | Drug: olmesartan medoxomilolmesartan medoxomil 10 to 20 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 (2 listed)
- Male and female subjects aged 20 years or older at informed consent
- Subjects with essential hypertension during run-in period (mean 24 hour systolic blood pressure SBP ≥ 130 and diastolic blood pressure DBP ≥ 80 mmHg and Sitting systolic blood pressure (SBP) ≥ 140 mmHg and < 180 mmHg, Sitting diastolic blood pressure (DBP) ≥ 90 mmHg and < 110 mmHg)
Key exclusion criteria (5 listed)
- Secondary hypertension or malignant hypertension
- Diabetes mellitus with albuminuria
- Serum potassium level < 3.5 or ≥ 5.1 milliequivalent (mEq)/L
- 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, oral | Drug | CS-3150 |
| olmesartan medoxomilAlso: Benicarolmesartan medoxomil 10 mg, oral | Drug | olmesartan medoxomil |
Primary outcome
Change from baseline in 24 hr blood pressure
Time frame: baseline to end of Week 12
Relationship between the change from baseline in 24 hr blood pressure (systolic, diastolic, and average blood pressure) and baseline factors frpm baseline to end of Week 12
4 secondary outcomes
Change from baseline in morning, evening, and night blood pressure.
Time frame: baseline to week 12
Change from baseline in sitting blood pressure
Time frame: baseline to week 12
Time course of 24 hr blood pressure and sitting blood pressure
Time frame: week 12
Proportion of patients achieving 24 hr and sitting blood pressure control
Time frame: 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/
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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
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 and olmesartan medoxomil 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 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 24 hr 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.