Essential HypertensionPhase 3NCT00857285
Olmesartan Medoxomil Versus Losartan in Patients With Hypertension
A Phase 3 study testing olmesartan medoxomil and losartan potassium in people with Essential Hypertension, run by Daiichi Sankyo at 3 sites in Taiwan.
Trial summary
The purpose of this study is to determine the efficacy and safety of oral administration of olmesartan medoxomil compared to losartan in subjects with mild to moderate hypertension. Read more about this study
- Who is it for?
- Ages 20 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
- 130 participants
- Where
- 3 sitesTaiwan
- Study dates
- May 2002to Sep 2003
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diastolic BP 95 mm Hg - 114 mm Hg inclusive
- No participation in any clinical trial for the last 3 months
Who cannot join
- Secondary hypertension
- Malignant hypertension
- Severe arterial hypertension
- Significant cardiovascular disease
- History or clinical evidence of cerebrovascular, gastrointestinal, hematological, hepatic disease, myocardial infarction, or severe liver disorder
- Clinical evidence of renal disease, poorly controlled diabetes, known malabsorption syndromes, psychiatric/emotional problems
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
Kaohsiung Medical University Hospital
Kaohsiung City
Chung Shun Medical University Hospital
Taichung
National Taiwan University Hospital
Taipei
About this study
Official title: A Multi-center, Double Blind, Efficacy, and Safety Study of the Oral Angiotensin II Receptor Blocker "Olmesartan Medoxomil" Versus "Losartan" in Patients With Mild to Moderate Essential Hypertension
The purpose of this study is to determine the efficacy and safety of oral administration of olmesartan medoxomil compared to losartan in subjects with mild to moderate 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
olmesartan medoxomil oral tablets, once daily for up to 12 weeks
losartan potassiumDrug
losartan oral tablets, once daily for up to 12 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.
Mean Change of Sitting dBP From Baseline to Week 12
The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startMay 2002
- Primary completionAug 2003
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Taiwan Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857285
- Sponsor's protocol ID
- TSP-866/01
- Status last verified
- Jul 2009
- First submitted
- 5 Mar 2009
- Last updated
- 23 Jul 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double Blind, Efficacy, and Safety Study of the Oral Angiotensin II Receptor Blocker "Olmesartan Medoxomil" Versus "Losartan" in Patients With Mild to Moderate Essential Hypertension
- ClinicalTrials.gov ID
- NCT00857285
- Acronym / sponsor ID
- TSP-866/01
- Conditions
- Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Taiwan Ltd.
- Study start
- May 2002
- Primary completion
- Aug 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 6 Mar 2009 (estimated)
- Results
- Posted 23 Jul 2009
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 determine the efficacy and safety of oral administration of olmesartan medoxomil compared to losartan in subjects with mild to moderate hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, 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
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diastolic BP 95 mm Hg - 114 mm Hg inclusive
- No participation in any clinical trial for the last 3 months
Key exclusion criteria (6 listed)
- Secondary hypertension
- Malignant hypertension
- Severe arterial hypertension
- Significant cardiovascular disease
- History or clinical evidence of cerebrovascular, gastrointestinal, hematological, hepatic disease, myocardial infarction, or severe liver disorder
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 medoxomilolmesartan medoxomil oral tablets, once daily for up to 12 weeks | Drug | 1 |
| losartan potassiumlosartan oral tablets, once daily for up to 12 weeks | Drug | 2 |
Primary outcome
Mean Change of Sitting dBP From Baseline to Week 12
Time frame: Baseline to 12 weeks
The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
3 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 3 sites in Taiwan.
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 6 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 23 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. 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?
Yes. Results are posted in the registry (first posted 23 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change of Sitting dBP From Baseline to Week 12 (time frame: Baseline to 12 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 23 Jul 2009.