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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: olmesartan medoxomil and a CCB; Drug: olmesartan medoxomil and a diuretic

• Registration Number: NCT00858702
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2005-07
• Study Completion: 2005-11
• Study First Submitted: 2009-03-09
• Study First Submitted QC: 2009-03-09
• Study First Posted: 2009-03-10
• Results First Submitted: 2009-07-16
• Results First Submitted QC: 2009-07-16
• Results First Posted: 2009-08-26
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	olmesartan medoxomil and a CCB	olmesartan medoxomil tablets and a CCB tablet (of the dihydropyridine class), once daily for 8 weeks
2	olmesartan medoxomil and a diuretic	olmesartan medoxomil and a diuretic tablet (of the thiazide class)

Primary Outcome Measures

Name	Time	Method
The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85	Baseline to week 8

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)	At week 8	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.
Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)	At week 8	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.