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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Daiichi Sankyo
- Enrollment
- 144
- Primary Endpoint
- Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment
Intervention: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary (Drug)
Outcomes
Primary Outcomes
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
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
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.
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.
Secondary Outcomes
No secondary outcomes reported