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

Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Essential Hypertension

Intervention: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Daiichi Sankyo Inc.

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.

Clinical Details

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

Primary outcome:

Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)

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)

Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)

Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)

Eligibility

Minimum age: 30 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: August 2006
Last updated: May 27, 2009

Page last updated: August 23, 2015

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