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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings) [ Time Frame: At week 8 ] [ Designated as safety issue: Yes ]
  • Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values) [ Time Frame: At week 8 ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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

No publications provided

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
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Daiichi Sankyo Inc.:
Essential hypertension
Combination therapy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Calcium Channel Blockers
Diuretics
Olmesartan medoxomil
Olmesartan
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Natriuretic Agents
Physiological Effects of Drugs
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents

ClinicalTrials.gov processed this record on July 29, 2014