Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension

Daiichi Sankyo

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: olmesartan medoxomil and a CCB; Drug: olmesartan medoxomil and a diuretic

Study type: Interventional

Funder types: Industry

Identifiers

NCT00858702

OLM004-071

Details and patient eligibility

About

The purpose of the study is to test the efficacy and safety of the combination of Calcium Channel Blockers (CCBs)(of the dihydropyridine class) or Diuretics (of the thiazide class) and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not adequately controlled with olmesartan medoxomil alone

Enrollment: 105 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mean seated blood pressure greater than or equal to 140/90 mmHg under circumstances in pre-treatment with olmesartan medoxomil
• Mean 24-hour blood pressure evaluated by ambulatory blood pressure monitoring greater than or equal to 135/80 mmHg under circumstances in pre-treatment with olmesartan medoxomil

Exclusion criteria

• Patients with secondary hypertension
• Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

1

Experimental group

Description:

olmesartan medoxomil tablets and a CCB tablet (of the dihydropyridine class), once daily for 8 weeks

Treatment:

Drug: olmesartan medoxomil and a CCB

2

Experimental group

Description:

olmesartan medoxomil and a diuretic tablet (of the thiazide class)

Treatment:

Drug: olmesartan medoxomil and a diuretic