HypertensionPhase 4NCT00185068
An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension
A Phase 4 study testing Olmesartan medoxomil, Olmesartan medoxomil/hydrochlorothiazide and Hydrochlorothiazide in people with Hypertension, run by Daiichi Sankyo at 16 sites in United States.
Trial summary
Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Olmesartan medoxomil, Olmesartan medoxomil/hydrochlorothiazide and Hydrochlorothiazide
- How many people
- 110 participants
- Where
- 16 sitesUnited States
- Study dates
- Mar 2004to Oct 2004
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 18 years of age.
- 2. Patients with stage II systolic hypertension
- 3. If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study.
Who cannot join
- 1. Hypertensive encephalopathy, stroke or transient ischemic attack (TIA) within the past 6 months.
- 2. History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months.
- 3. Severe hypertension (DBP greater than or equal to 110 mm Hg or SBP > 200 mm Hg).
- 4. History of secondary hypertension including renal disease, phaeochromocytoma, or Cushing's disease.
- 5. Type I diabetes mellitus. 6. Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.
- 7. Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter.
Show all 10Show fewer
- 8. Laboratory test values considered clinically significant by the investigator.
- 9. Evidence of liver disease as indicated by SGOT or SGPT and/or total bilirubin > 3 times the upper limit of normal.
- 10. Pregnant or lactating females.
- 11. Patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Study site
Auburn, Maine
Study site
Buffalo, New York
Study site
DeLand, Florida
Study site
Fort Lauderdale, California
Study site
Long Beach, California
Study site
Madison, Wisconsin
Study site
New Orleans, Louisiana
Study site
Oklahoma City, Oklahoma
Study site
Omaha, Nebraska
Study site
Orland Park, Illinois
Study site
Pembroke Pines, Florida
Study site
Roseville, California
Study site
Sacramento, California
Study site
Santa Anna, California
Study site
Tustin, California
Study site
Westlake Village, California
About this study
Official title: A Prospective, Open Label, Titration Study to Assess the Efficacy and Safety of Benicar® and Benicar ®HCT in Patients With Stage II Systolic Hypertension
Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension
- Conditions
- Hypertension
- Being tested
- Olmesartan medoxomil, Olmesartan medoxomil/hydrochlorothiazide, Hydrochlorothiazide
- Keywords
- Systolic hypertension, Angiotensin receptor blocker
- Medical subject headings
- Hypertension, Isolated Systolic Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olmesartan medoxomilDrug
Olmesartan medoxomil/hydrochlorothiazideDrug
HydrochlorothiazideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean trough seated systolic blood pressure compared to the start of the study
Secondary outcomes (3)
1. Blood pressure changes from baseline at the end of each titration period.
2. Percentage of patients responding to therapy
3. Percentage of patients achieving various blood pressure target goals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185068
- Sponsor's protocol ID
- 866-443
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 16 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Titration Study to Assess the Efficacy and Safety of Benicar® and Benicar ®HCT in Patients With Stage II Systolic Hypertension
- ClinicalTrials.gov ID
- NCT00185068
- Acronym / sponsor ID
- 866-443
- Conditions
- Hypertension
- Keywords
- Systolic hypertension, Angiotensin receptor blocker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Oct 2004
- First posted
- 16 Sep 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.
Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. 18 years of age.
- 2. Patients with stage II systolic hypertension
- 3. If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study.
Key exclusion criteria (10 listed)
- 1. Hypertensive encephalopathy, stroke or transient ischemic attack (TIA) within the past 6 months.
- 2. History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months.
- 3. Severe hypertension (DBP greater than or equal to 110 mm Hg or SBP > 200 mm Hg).
- 4. History of secondary hypertension including renal disease, phaeochromocytoma, or Cushing's disease.
- 5. Type I diabetes mellitus. 6. Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.
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 medoxomil | Drug | – |
| Olmesartan medoxomil/hydrochlorothiazide | Drug | – |
| Hydrochlorothiazide | Drug | – |
Primary outcome
Change in mean trough seated systolic blood pressure compared to the start of the study
3 secondary outcomes
1. Blood pressure changes from baseline at the end of each titration period.
2. Percentage of patients responding to therapy
3. Percentage of patients achieving various blood pressure target goals
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 16 Sep 2005.
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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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olmesartan medoxomil, Olmesartan medoxomil/hydrochlorothiazide and Hydrochlorothiazide in people with Hypertension, run by Daiichi Sankyo at 16 sites in United States.
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 3 inclusion and 10 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 16 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 in mean trough seated systolic blood pressure compared to the start of the study. 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 16 Sep 2005.