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

This study has been completed.

Sponsor:

Information provided by:

Daiichi Sankyo, Inc.

ClinicalTrials.gov Identifier:

NCT00858702

First received: March 9, 2009

Last updated: September 18, 2009

Last verified: September 2009

History of Changes

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: olmesartan medoxomil and a CCB Drug: olmesartan medoxomil and a diuretic	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Add-on Study of CCBs or Diuretics in Essential Hypertension Not Achieving Target Blood Pressure on Olmesartan Medoxomil Alone

Resource links provided by NLM:

Drug Information available for: Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo, Inc.:

Primary Outcome Measures:

The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85 [ Time Frame: Baseline to week 8 ]

Secondary Outcome Measures:

Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings) [ Time Frame: At week 8 ]
Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values) [ Time Frame: At week 8 ]


Enrollment:	105
Study Start Date:	February 2005
Study Completion Date:	November 2005
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 olmesartan medoxomil tablets and a CCB tablet (of the dihydropyridine class), once daily for 8 weeks	Drug: olmesartan medoxomil and a CCB olmesartan medoxomil tablets and a CCB tablet once daily for 8 weeks
Experimental: 2 olmesartan medoxomil and a diuretic tablet (of the thiazide class)	Drug: olmesartan medoxomil and a diuretic olmesartan medoxomil tablets and a diuretic tablet, once daily for 8 weeks

Eligibility


Ages Eligible for Study:	20 Years to 74 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858702

Locations


Japan

Tokyo, Japan

Sponsors and Collaborators

Daiichi Sankyo Co., Ltd.

Investigators


Study Director:	Research and Development Division	Daiichi Sankyo Co., Ltd.

More Information


Responsible Party:	Yoshihiro Kakehi, Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00858702 History of Changes
Other Study ID Numbers:	OLM004-071
Study First Received:	March 9, 2009
Results First Received:	July 16, 2009
Last Updated:	September 18, 2009

Keywords provided by Daiichi Sankyo, Inc.:


Essential hypertension Combination therapy

Additional relevant MeSH terms:


Hypertension Vascular Diseases Cardiovascular Diseases Diuretics Olmesartan Olmesartan Medoxomil Calcium Channel Blockers	Natriuretic Agents Physiological Effects of Drugs Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Membrane Transport Modulators

ClinicalTrials.gov processed this record on August 21, 2017

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