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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

March 9, 2009
September 18, 2009
February 2005
July 2005   (final data collection date for primary outcome measure)
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 ]
The percentages of patients achieving target BP of sitting BP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00858702 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Reduction in blood pressure evaluated by ABPM (daytime, nighttime, 24-hour) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Reduction in sitting diastolic and systolic blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension
Add-on Study of CCBs or Diuretics in Essential Hypertension Not Achieving Target Blood Pressure on Olmesartan Medoxomil Alone

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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • Drug: olmesartan medoxomil and a CCB
    olmesartan medoxomil tablets and a CCB tablet once daily for 8 weeks
  • Drug: olmesartan medoxomil and a diuretic
    olmesartan medoxomil tablets and a diuretic tablet, once daily for 8 weeks
  • Experimental: 1
    olmesartan medoxomil tablets and a CCB tablet (of the dihydropyridine class), once daily for 8 weeks
    Intervention: Drug: olmesartan medoxomil and a CCB
  • Experimental: 2
    olmesartan medoxomil and a diuretic tablet (of the thiazide class)
    Intervention: Drug: olmesartan medoxomil and a diuretic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
November 2005
July 2005   (final data collection date for primary outcome measure)

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
Both
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00858702
OLM004-071
No
Yoshihiro Kakehi, Daiichi Sankyo Co., Ltd.
Daiichi Sankyo Co., Ltd.
Not Provided
Study Director: Research and Development Division Daiichi Sankyo Co., Ltd.
Daiichi Sankyo Inc.
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP