Essential HypertensionPhase 3NCT00856271
Olmesartan Medoxomil Versus Losartan Potassium in Patients With Mild to Moderate Essential Hypertension
A Phase 3 study testing olmesartan medoxomil and losartan potassium in people with Essential Hypertension, run by Daiichi Sankyo at 5 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of olmesartan medoxomil compared with losartan potassium in patients with mild to moderate essential hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- olmesartan medoxomil and losartan potassium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 5 sitesChina
- Study dates
- Aug 2004to Apr 2005
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild to moderated essential hypertension (mean seated diastolic blood pressure ≥ 95 mmHg and <110 mmHg, mean seated systolic blood pressure < 180 mmHg)
- able to give written informed consent
Who cannot join
- known or suspected secondary hypertension
- history of chronic hepatic diseases
- obstructive hypertrophic cardiomyopathy/clinically significant valvular heart disease
- cardiac arrhythmia
- unstable angina pectoris
- congestive heart insufficiency (New York Heart Association classification III-IV)
Show all 13Show fewer
- bilateral renal artery stenosis
- isolated renal artery stenosis
- post renal transplantation
- history of acute myocardial infarction/percutaneous transluminal coronary angioplasty or heart surgery within three months before enrollment
- retina bleeding/effusion
- insulin dependent diabetes mellitus
- uncontrolled non-insulin dependent diabetes mellitus
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Study site
Beijing
Study site
Chongqing
Study site
Guangzhou
Study site
Nanjing
Study site
Shanghai
About this study
Official title: A Randomized, Double-blind, Double-dummy, Multi-center Study to Investigate the Safety and Efficacy of Olmesartan Medoxomil Compared With Losartan Potassium in Patients With Mild to Moderate Essential Hypertension
The purpose of this study is to evaluate the efficacy and safety of olmesartan medoxomil compared with losartan potassium in patients with mild to moderate essential hypertension.
- Conditions
- Essential Hypertension
- Being tested
- olmesartan medoxomil, losartan potassium
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olmesartan medoxomilDrug
oral tablets, once daily for 8 weeks
losartan potassiumDrug
capsules, once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | olmesartan medoxomil Receives: Drug: olmesartan medoxomil |
| 2 | Active comparator | losartan potassium Receives: Drug: losartan potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of trough seated diastolic blood pressure from baseline to 8 weeks
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2009 (estimated)
- Study startAug 2004
- Primary completionFeb 2005
- Study completionApr 2005
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.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Sankyo Pharmaceuticals Co., Ltd.
- Investigators
- Vice President, Study director, Sankyo Shanghai Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856271
- Sponsor's protocol ID
- SS-866/01
- Status last verified
- Sep 2010
- First submitted
- 3 Mar 2009
- Last updated
- 29 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Multi-center Study to Investigate the Safety and Efficacy of Olmesartan Medoxomil Compared With Losartan Potassium in Patients With Mild to Moderate Essential Hypertension
- ClinicalTrials.gov ID
- NCT00856271
- Acronym / sponsor ID
- SS-866/01
- Conditions
- Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Sankyo Pharmaceuticals Co., Ltd.
- Study start
- Aug 2004
- Primary completion
- Feb 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 5 Mar 2009 (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.
The purpose of this study is to evaluate the efficacy and safety of olmesartan medoxomil compared with losartan potassium in patients with mild to moderate essential hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: olmesartan medoxomilolmesartan medoxomil |
| 2 | Active comparator | Drug: losartan potassiumlosartan potassium |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- mild to moderated essential hypertension (mean seated diastolic blood pressure ≥ 95 mmHg and <110 mmHg, mean seated systolic blood pressure < 180 mmHg)
- able to give written informed consent
Key exclusion criteria (13 listed)
- known or suspected secondary hypertension
- history of chronic hepatic diseases
- obstructive hypertrophic cardiomyopathy/clinically significant valvular heart disease
- cardiac arrhythmia
- unstable angina pectoris
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 |
|---|---|---|
| olmesartan medoxomiloral tablets, once daily for 8 weeks | Drug | 1 |
| losartan potassiumcapsules, once daily for 8 weeks | Drug | 2 |
Primary outcome
Change of trough seated diastolic blood pressure from baseline to 8 weeks
Time frame: Baseline to 8 weeks
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 29 Sep 2010.
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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.
Vice President study director
Sankyo Shanghai Pharmaceuticals
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing olmesartan medoxomil and losartan potassium in people with Essential Hypertension, run by Daiichi Sankyo at 5 sites in China.
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 13 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 29 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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 of trough seated diastolic blood pressure from baseline to 8 weeks (time frame: Baseline to 8 weeks). 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 29 Sep 2010.