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

Hypertension Clinical Trial

Official title:

Add-on Study of CCBs or Diuretics in Essential Hypertension Not Achieving Target Blood Pressure on Olmesartan Medoxomil Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858702
• Other study ID #: OLM004-071
• Status: Completed
• Phase: Phase 4
• First received: March 9, 2009
• Last updated: October 10, 2017
• Start date: February 2005
• Est. completion date: November 2005

Study information

• Verified date: October 2017
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: November 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• olmesartan medoxomil and a CCB
olmesartan medoxomil tablets and a CCB tablet once daily for 8 weeks
• olmesartan medoxomil and a diuretic
olmesartan medoxomil tablets and a diuretic tablet, once daily for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85		Baseline to week 8
Secondary	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.	At week 8
Secondary	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.	At week 8