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

Daiichi Sankyo Co., Ltd.105 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

105

Conditions

Hypertension

Interventions

olmesartan medoxomil and a CCBDRUG

olmesartan medoxomil tablets and a CCB tablet once daily for 8 weeks

olmesartan medoxomil and a diureticDRUG

olmesartan medoxomil tablets and a diuretic tablet, once daily for 8 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85

Time frame: Baseline to week 8

Secondary Outcomes

Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)

Drug-related adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.

Time frame: At week 8

Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)

Drug-related, laboratory value change adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.

Time frame: At week 8

Data from ClinicalTrials.gov

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