HypertensionNCT00811226
Assessment of the Effectiveness of OLMETEC® and OLMETEC PLUS® for Treatment of Hypertension in Stage I and II Patients (Study P05254)(COMPLETED)
An observational study of Hypertension, run by Schering-Plough.
Trial summary
The purpose of this study is to determine the efficiency of Olmesartan medoxomile (OLMETEC®) alone or in combination with hydrochlorothiazide (OLMETEC PLUS®) in the reduction of arterial blood pressure in patients with light to moderate hypertension, and to evaluate the percentage of patients that reach treatment… 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 medoxomile alone or combined with hydrochlorothiazide,
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Jan 2008
- Phase
- Observational
- 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
Study population: Patients in Venezuela with arterial hypertension Stade I or Stade II
Who may be able to join
- Men or women 18 years of age or older
- Essential arterial hypertension Stade I and II according to JNC VII
- Signature of Informed Consent
Who cannot join
- Secondary arterial hypertension
- Pregnant woman or during lactancy
- Recent cardiovascular disease, as heart attack, unstable angina, or procedures of coronary revascularization on the previous six months.
- Acute Coronary Failure Syndrome on the previous six months.
- Chronic Ischemic Cardiopathy Treatment.
- Cerebral Vascular Disease on the previous six months.
Show all 20Show fewer
- Alcoholism Story or use of drugs on the two previous years.
- Hepatic Disease Story
- Chronic Renal Failure defined by a serumal creatinine higher than 2mg/dl
- Albuminuria higher than 1gr.
- Known Allergy to blockers of angiotensine II receptors.
- Neoplasmic Malignant Disease included leukemia and the lymphoma (Skin basocellular cancer is not included)
- Auto Immune Disorders as systemic erythematosus lupus.
- Non attachment to medical treatments history.
- Patients sharing some clinical investigation essay on the last 3 months.
- Congestive heart failure under previous treatment with ECA inhibitors.
- Allergy to thiazidic diuretics.
- Angioedema History
- Use of drugs that affect potassium secretion, as diuretic savers of potassium, angiotensine enzyme inhibitor, betablockers, non-steroid anti-inflammatory drugs.
- Potassium consumption orally
About this study
Official title: Prospective, Multicentric, Open Clinic Essay to Evaluate the Use of OLMETEC® (Olmesartan Medoxomile) and OLMETEC PLUS® (Olmesartan Medoxomile Hydrochlorothiazide) in Stade I and II, According to JNC VII
The purpose of this study is to determine the efficiency of Olmesartan medoxomile (OLMETEC®) alone or in combination with hydrochlorothiazide (OLMETEC PLUS®) in the reduction of arterial blood pressure in patients with light to moderate hypertension, and to evaluate the percentage of patients that reach treatment goals using this antihypertensive regimen.
Read the detailed description
α= 0.05. α's Z=1.96 β= 80%. β's Z=0.84 Estimated proportion of subjects to achieve optimal control of arterial hypertension= 83.2%
450 subjects are expected to be enrolled in the study of which 40 subjects will be enrolled in Venezuela.
- Conditions
- Hypertension
- Being tested
- olmesartan medoxomile alone or combined with hydrochlorothiazide,
- Keywords
- Hypertension Stage I, Hypertension Stage II
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olmesartan medoxomile alone or combined with hydrochlorothiazide,Drug
Also called SCH 900332, OLMETEC®, OLMETEC PLUS ®
olmesartan medoxomile 20mg/daily or 40mg/daily; olmesartan medoxomile 20mg plus 12.5 mg of hydrochlorothiazide daily; olmesartan medoxomile 40mg plus 12.5 mg of hydrochlorothiazide daily
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with arterial hypertension Stade I or Stade II Receives: Drug: olmesartan medoxomile alone or combined with hydrochlorothiazide, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing diastolic pressure
Measured: basal registry and on follow-up visits in weeks 4, 8, 12, and 16
Secondary outcomes (2)
Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing systolic pressure
Measured: basal registry and on follow-up visits in weeks 4, 8, 12, and 16
Evaluation of the percentage of patients (including diabetics and those with renal disease) that achieve arterial blood pressure treatment goals with Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®)
Measured: basal registry and on follow-up visits in weeks 4, 8, 12, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startApr 2007
- Primary completionJan 2008
- Study completionJan 2008
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schering-Plough
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811226
- Sponsor's protocol ID
- P05254
- Status last verified
- Dec 2008
- First submitted
- 25 Jul 2008
- Last updated
- 18 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentric, Open Clinic Essay to Evaluate the Use of OLMETEC® (Olmesartan Medoxomile) and OLMETEC PLUS® (Olmesartan Medoxomile Hydrochlorothiazide) in Stade I and II, According to JNC VII
- ClinicalTrials.gov ID
- NCT00811226
- Acronym / sponsor ID
- P05254
- Conditions
- Hypertension
- Keywords
- Hypertension Stage I, Hypertension Stage II
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Schering-PloughIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 18 Dec 2008 (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 determine the efficiency of Olmesartan medoxomile (OLMETEC®) alone or in combination with hydrochlorothiazide (OLMETEC PLUS®) in the reduction of arterial blood pressure in patients with light to moderate hypertension, and to evaluate the percentage of patients that reach treatment goals using this antihypertensive regimen.
Detailed description
α= 0.05. α's Z=1.96 β= 80%. β's Z=0.84 Estimated proportion of subjects to achieve optimal control of arterial hypertension= 83.2%
450 subjects are expected to be enrolled in the study of which 40 subjects will be enrolled in Venezuela.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Drug: olmesartan medoxomile alone or combined with hydrochlorothiazide,Patients with arterial hypertension Stade I or Stade II |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in Venezuela with arterial hypertension Stade I or Stade II
Key inclusion criteria (3 listed)
- Men or women 18 years of age or older
- Essential arterial hypertension Stade I and II according to JNC VII
- Signature of Informed Consent
Key exclusion criteria (20 listed)
- Secondary arterial hypertension
- Pregnant woman or during lactancy
- Recent cardiovascular disease, as heart attack, unstable angina, or procedures of coronary revascularization on the previous six months.
- Acute Coronary Failure Syndrome on the previous six months.
- Chronic Ischemic Cardiopathy Treatment.
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 medoxomile alone or combined with hydrochlorothiazide,Also: SCH 900332, OLMETEC®, OLMETEC PLUS ®olmesartan medoxomile 20mg/daily or 40mg/daily; olmesartan medoxomile 20mg plus 12.5 mg of hydrochlorothiazide daily; olmesartan medoxomile 40mg plus 12.5 mg of hydrochlorothiazide daily | Drug | Patients |
Primary outcome
Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing diastolic pressure
Time frame: basal registry and on follow-up visits in weeks 4, 8, 12, and 16
2 secondary outcomes
Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing systolic pressure
Time frame: basal registry and on follow-up visits in weeks 4, 8, 12, and 16
Evaluation of the percentage of patients (including diabetics and those with renal disease) that achieve arterial blood pressure treatment goals with Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®)
Time frame: basal registry and on follow-up visits in weeks 4, 8, 12, and 16
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 18 Dec 2008.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Schering-Plough.
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 20 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 18 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing diastolic pressure (time frame: basal registry and on follow-up visits in weeks 4, 8, 12, and 16). 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 18 Dec 2008.