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Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension (Benibest)

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ClinicalTrials.gov Identifier: NCT00890591
Recruitment Status : Completed
First Posted : April 30, 2009
Results First Posted : April 30, 2009
Last Update Posted : June 3, 2009
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Brief Summary:
In patients naive to treatment or after a 2-week washout period for patients whose treatment was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme: monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: National, Multicenter, Open-Label and Prospective Study Assessment of Efficacy and Safety in Stage 1 and 2 Essential Hypertension With Olmesartan Medoxomil Based Treatment Algorithm From Monotherapy to Association With Hydrochlorothiazide and Amlodipine Besylate
Study Start Date : August 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary
olmesartan medoxomil tablets,or olmesartan medoxomil/hydrochlorothiazide tablets, if necessary + amlodipine tablets, if necessary. All interventions are once-daily for 4 to 9 weeks




Primary Outcome Measures :
  1. Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy) [ Time Frame: 4 - 9 wks of olmesartan monotherapy ]
  2. Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide) [ Time Frame: 4 to 9 weeks on combination therapy ]
  3. Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide) [ Time Frame: 4 to 9 weeks ]
  4. Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine) [ Time Frame: 4 - 9 weeks ]


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage 1 and 2 hypertension without treatment for at least 2 weeks
  • Women with no risk of becoming pregnant

Exclusion Criteria:

  • Study participation could result in risk to health of subject
  • Cardiovascular disease
  • Secondary hypertension or stage 3 hypertension
  • Myocardial infarction within the last 6 months
  • Congestive heart failure
  • Pulmonary edema
  • Valvular alterations or rheumatic cardiopathy
  • Clinically relevant conduction disorders significant arrhythmias
  • Alcohol or illicit drug use
  • Medication abuse
  • Pregnant or nursing women

Responsible Party: Medical Affairs Manager, Daiichi Sankyo Brazil
ClinicalTrials.gov Identifier: NCT00890591     History of Changes
Other Study ID Numbers: SPB-OM-0106
First Posted: April 30, 2009    Key Record Dates
Results First Posted: April 30, 2009
Last Update Posted: June 3, 2009
Last Verified: May 2009

Keywords provided by Daiichi Sankyo, Inc.:
hypertension
angiotensin II type 1 receptor blocker
olmesartan

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan
Amlodipine
Hydrochlorothiazide
Olmesartan Medoxomil
Angiotensin II Type 1 Receptor Blockers
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Angiotensin Receptor Antagonists