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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.

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: N/A
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

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Arms and Interventions
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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


Outcome Measures
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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 ]
    Number of patients that achieved a blood pressure (BP) goal of less than 130/85 in the first group (olmesartan monotherapy 20 mg). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level for an additional 4-9 weeks at the next medication level

  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 ]
    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)If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks

  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 ]
    Number of patients that achieved a blood pressure goal of less than 130/85 in second titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 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 ]
    Number of patients that achieved a blood pressure goal of less than 130/85 in third titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide + amlodipine 5 mg). This combination was maintained as long as the participant's blood pressure remained within predefined parameters. If not, participant discontinued for lack of efficacy.


Eligibility Criteria
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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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Medical Affairs Manager, Daiichi Sankyo Brazil
ClinicalTrials.gov Identifier: NCT00890591    
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:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Hydrochlorothiazide
Olmesartan
Olmesartan Medoxomil
Antihypertensive Agents
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists