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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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: olmesartan medoxomil and a CCB
Drug: olmesartan medoxomil and a diuretic
Enrollment 105
Recruitment Details A total of 172 patients were enrolled at 5 centers in Japan from February 12, 2005 to April 30, 2005.
Pre-assignment Details After the 4 to 6 weeks of olmesartan medoxomil monotherapy period, 105 patients who met the entry criteria for the combination therapy period were randomized to calcium channel blocker (of the dihydropyridine class) combination group or diuretic (of the thiazide class)combination group.
Arm/Group Title Olmesartan Tablets and a Calcium Channel Blocker Tablet Olmesartan Medoxomil Tablets and a Diuretic Tablet
Hide Arm/Group Description olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class)once daily for 8 weeks
Period Title: Overall Study
Started 53 52
Completed 48 50
Not Completed 5 2
Reason Not Completed
Lack of Efficacy             1             0
Protocol Violation             1             1
Other             2             1
Withdrawal by Subject             1             0
Arm/Group Title Olmesartan Tablets and a Calcium Channel Blocker Tablet Olmesartan Medoxomil Tablets and a Diuretic Total
Hide Arm/Group Description olmesartan medoxomil tablets and a calcium channel blocker tablet, once daily for 8 weeks olmesartan medoxomil tablets and a diuretic once daily for 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 53 52 105
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 52 participants 105 participants
56.2  (11.2) 57.4  (9.4) 56.8  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 52 participants 105 participants
Female
22
  41.5%
20
  38.5%
42
  40.0%
Male
31
  58.5%
32
  61.5%
63
  60.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Japanese Number Analyzed 53 participants 52 participants 105 participants
53 52 105
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 53 participants 52 participants 105 participants
53 52 105
1.Primary Outcome
Title The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85
Hide Description [Not Specified]
Time Frame Baseline to week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Primary analysis was conducted for full analysis set. It excluded the patients who were not administrated study drugs, or did not satisfy entry criteria, or had no data after randomisation.
Arm/Group Title Olmesartan Tablets and a Calcium Channel Blocker Tablet Olmesartan Medoxomil Tablets and a Diuretic
Hide Arm/Group Description:
olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class) once daily for 8 weeks
Overall Number of Participants Analyzed 50 49
Measure Type: Number
Unit of Measure: Percent of participants
34.0 59.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan Tablets and a Calcium Channel Blocker Tablet, Olmesartan Medoxomil Tablets and a Diuretic
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0158
Comments No consideration for multiplicity
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)
Hide Description 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.
Time Frame At week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis (Clinical AEs:subjective symptoms / objective findings) was conducted for Safety Population. It excluded the patients who were not administrated study drugs.
Arm/Group Title Olmesartan Tablets and a Calcium Channel Blocker Tablet Olmesartan Medoxomil Tablets and a Diuretic
Hide Arm/Group Description:
olmesartan medoxomil tablets and a calcium channel blocker (of the dihydropyridine class) tablet, once daily for 8 weeks
olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class) once daily for 8 weeks
Overall Number of Participants Analyzed 53 52
Measure Type: Number
Unit of Measure: Percent of participants
0 7.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan Tablets and a Calcium Channel Blocker Tablet, Olmesartan Medoxomil Tablets and a Diuretic
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0566
Comments No consideration for multiplicity
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)
Hide Description 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.
Time Frame At week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis (laboratory AEs:abnormal changes in clinical laboratory values) was conducted for Safety Population. It excluded the patients who were not administered study drugs, or had no clinical laboratory data.
Arm/Group Title Olmesartan Tablets and a Calcium Channel Blocker Tablet Olmesartan Medoxomil Tablets and a Diuretic
Hide Arm/Group Description:
olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
olmesartan medoxomil tablets and a diuretic tablet(of the the thiazide class) once daily for 8 weeks
Overall Number of Participants Analyzed 52 52
Measure Type: Number
Unit of Measure: Percent of participants
1.9 44.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan Tablets and a Calcium Channel Blocker Tablet, Olmesartan Medoxomil Tablets and a Diuretic
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No consideration for multiplicity
Method Fisher Exact
Comments [Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Howard Kessler
Organization: Daiichi Sankyo
Phone: 732-590-5032
EMail: hmkessler@dsi.com
Layout table for additonal information
Responsible Party: Yoshihiro Kakehi, Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT00858702     History of Changes
Other Study ID Numbers: OLM004-071
First Submitted: March 9, 2009
First Posted: March 10, 2009
Results First Submitted: July 16, 2009
Results First Posted: August 26, 2009
Last Update Posted: October 11, 2017