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

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ClinicalTrials.gov Identifier: NCT00858702
Recruitment Status : Completed
First Posted : March 10, 2009
Results First Posted : August 26, 2009
Last Update Posted : October 11, 2017
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

March 9, 2009
March 10, 2009
July 16, 2009
August 26, 2009
October 11, 2017
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 ]
The percentages of patients achieving target BP of sitting BP [ Time Frame: 8 weeks ]
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 ]
    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) [ Time Frame: 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.
  • Reduction in blood pressure evaluated by ABPM (daytime, nighttime, 24-hour) [ Time Frame: 8 weeks ]
  • Reduction in sitting diastolic and systolic blood pressure [ Time Frame: 8 weeks ]
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
Intervention Model: Parallel Assignment
Masking: None (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
Same as current
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
Sexes Eligible for Study: All
20 Years to 74 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00858702
OLM004-071
No
Not Provided
Not Provided
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.
October 2017

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