Essential HypertensionPhase 3OSCARNCT00139698
Olmesartan Alone or in Combination With Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension
A Phase 3 study testing olmesartan alone or in combination with hydrochlorothiazide in people with Essential Hypertension, run by Pfizer at 32 sites in 11 countries.
Trial summary
Efficacy, tolerability and safety of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- olmesartan alone or in combination with hydrochlorothiazide
- How many people
- 410 participants
- Where
- 32 sitesin 11 countries
- Study dates
- Sep 2005to Jul 2006
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has mild to moderate hypertension
Who cannot join
- History of secondary hypertension
Trial locations and contacts
32 sites in 11 countries.
32 sites in 11 countries
Colombia5 sites
Pfizer Investigational Site
Barranquilla, Atlántico
Pfizer Investigational Site
Bogota, Cundinamarca
Pfizer Investigational Site
Cali, Valle del Cauca Department
Pfizer Investigational Site
Cartagena, Atlántico
Pfizer Investigational Site
Medellín, Antioquia
Indonesia4 sites
Pfizer Investigational Site
Jakarta, 10430
Pfizer Investigational Site
Jakarta, 11420
Pfizer Investigational Site
Jakarta
Pfizer Investigational Site
Surabaya, 60286
Taiwan4 sites
Pfizer Investigational Site
Guei-Shan Shiang, Tau-Yuan Shian, 333
Pfizer Investigational Site
Kaohsiung City, 813
Pfizer Investigational Site
Taipei, 106
Pfizer Investigational Site
Taipei, 112
Thailand4 sites
Pfizer Investigational Site
Bangkok, 10400
Pfizer Investigational Site
Bangkok, 10700
Pfizer Investigational Site
Chiang Mai, 50200
Pfizer Investigational Site
Khet Rajathevee, Bangkok, 10400
Turkey (Türkiye)4 sites
Pfizer Investigational Site
Bornova/Izmir, 35100
Pfizer Investigational Site
Haseki/Istanbul, 34390
Pfizer Investigational Site
S¿hhiye/Ankara, 06100
Pfizer Investigational Site
Sihhiye/Ankara, 06100
Ecuador2 sites
Pfizer Investigational Site
Escobedo, Guayas
Pfizer Investigational Site
Quito, Pichincha
Hong Kong2 sites
Pfizer Investigational Site
NT
Pfizer Investigational Site
Shatin, NT
Malaysia2 sites
Pfizer Investigational Site
Kuching, Sarawak, 93586
Pfizer Investigational Site
Seremban, Negeri Sembilan, 70300
Philippines2 sites
Pfizer Investigational Site
Quezon
Pfizer Investigational Site
San Juan City, National Capital Region
Singapore2 sites
Pfizer Investigational Site
Singapore, 119074
Pfizer Investigational Site
Singapore, 169608
Location not given1 site
Pfizer Investigational Site
About this study
Official title: A Phase III, Multicenter, Open-Label, Dose-Titrating, 16-Week Study Evaluating The Efficacy, Tolerability and Safety of Olmesartan Medoxomil 20 Mg and 40 Mg Alone or in Combination With 12.5 Mg to 25 Mg of Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension
Efficacy, tolerability and safety of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension
- Conditions
- Essential Hypertension
- Being tested
- olmesartan alone or in combination with hydrochlorothiazide
- 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 alone or in combination with hydrochlorothiazideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension
Secondary outcomes (1)
Safety and tolerability of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startSep 2005
- Study completionJul 2006
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 PfizerThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 410 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139698
- Sponsor's protocol ID
- A0021002
- Acronym
- OSCAR
- Status last verified
- Dec 2018
- First submitted
- 29 Aug 2005
- Last updated
- 5 Dec 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Open-Label, Dose-Titrating, 16-Week Study Evaluating The Efficacy, Tolerability and Safety of Olmesartan Medoxomil 20 Mg and 40 Mg Alone or in Combination With 12.5 Mg to 25 Mg of Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension
- ClinicalTrials.gov ID
- NCT00139698
- Acronym / sponsor ID
- OSCAR / A0021002
- Conditions
- Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Jul 2006
- First posted
- 31 Aug 2005 (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.
Efficacy, tolerability and safety of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject has mild to moderate hypertension
Key exclusion criteria (1 listed)
- History of secondary hypertension
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 alone or in combination with hydrochlorothiazide | Drug | – |
Primary outcome
Efficacy of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension
1 secondary outcome
Safety and tolerability of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension
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 5 Dec 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
32 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing olmesartan alone or in combination with hydrochlorothiazide in people with Essential Hypertension, run by Pfizer at 32 sites in 11 countries.
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 1 inclusion and 1 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 5 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 32 sites in Colombia, Indonesia, Taiwan, Thailand, Turkey (Türkiye) and 5 more countries. 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?
Efficacy of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension. 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 5 Dec 2018.