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

Essential Hypertension Clinical Trial

— Benibest  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890591
• Other study ID #: SPB-OM-0106
• Status: Completed
• Phase: Phase 4
• First received: February 11, 2009
• Last updated: May 27, 2009
• Start date: August 2006
• Est. completion date: August 2007

Study information

• Verified date: May 2009
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: August 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)		4 - 9 wks of olmesartan monotherapy	No
Primary	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)		4 to 9 weeks on combination therapy	No
Primary	Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)		4 to 9 weeks	No
Primary	Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)		4 - 9 weeks	No