Assessment of the Effectiveness of OLMETEC® and OLMETEC PLUS® for Treatment of Hypertension in Stage I and II Patients (Study P05254)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00811226
First received: July 25, 2008
Last updated: December 16, 2008
Last verified: December 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypertension |
Drug: olmesartan medoxomile alone or combined with hydrochlorothiazide, |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 450 |
| Study Start Date: | April 2007 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Patients
Patients with arterial hypertension Stade I or Stade II
|
Drug: olmesartan medoxomile alone or combined with hydrochlorothiazide,
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
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients in Venezuela with arterial hypertension Stade I or Stade II
Criteria
Inclusion Criteria:
- Men or women 18 years of age or older
- Essential arterial hypertension Stade I and II according to JNC VII
- Signature of Informed Consent
Exclusion Criteria:
- 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.
- 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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00811226 History of Changes |
| Other Study ID Numbers: | P05254 |
| Study First Received: | July 25, 2008 |
| Last Updated: | December 16, 2008 |
| Health Authority: | Venezuela: Instituto Nacional De Higiene "Rafael Rangel" |
Keywords provided by Schering-Plough:
|
Hypertension Stage I Hypertension Stage II |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Olmesartan medoxomil Olmesartan Diuretics Natriuretic Agents Physiological Effects of Drugs |
Pharmacologic Actions Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013