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

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Company Brazil
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00890591
First received: February 11, 2009
Last updated: May 27, 2009
Last verified: May 2009
History of Changes
  Purpose

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 Intervention Phase
Essential Hypertension
 Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 144
Study Start Date: August 2006
Study Completion Date: August 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Medical Affairs Manager, Daiichi Sankyo Brazil
ClinicalTrials.gov Identifier: NCT00890591     History of Changes
Other Study ID Numbers: SPB-OM-0106
Study First Received: February 11, 2009
Results First Received: February 11, 2009
Last Updated: May 27, 2009
Health Authority: Brazil: Ethics Committee

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Olmesartan medoxomil
Amlodipine
Olmesartan
Angiotensin II Type 1 Receptor Blockers
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
Calcium Channel Blockers
Vasodilator Agents
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 22, 2013