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:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00811226
First received: July 25, 2008
Last updated: December 16, 2008
Last verified: December 2008
  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:
  • SCH 900332
  • OLMETEC®
  • OLMETEC PLUS ®

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Olmesartan
Olmesartan medoxomil
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 19, 2014