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Trial record 35 of 134 for:    OLMESARTAN

An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Patients With Type II Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00403481
Recruitment Status : Completed
First Posted : November 23, 2006
Results First Posted : September 15, 2009
Last Update Posted : November 3, 2016
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: olmesartan medoxomil
Drug: Olmesartan medoxomil plus Hydrochlorothiazide
Enrollment 192
Recruitment Details Subjects were recruited at 24 US sites over 10 months from November 2006 to August 2007 from each physician’s clientele base. Approximately 200 eligible subjects, men and women at least 18 years of age with stage I/II hypertension and stable type 2 diabetes mellitus, were to be enrolled on active treatment.
Pre-assignment Details 192 participants started this single arm titration study. Participants remained in their group or were titrated at 3-week intervals depending on achievement their blood pressure goals.
Arm/Group Title Active Treatment Period
Hide Arm/Group Description All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
Period Title: Olmesartan Medoxomil (Olm) 20 mg
Started 192
Completed 186
Not Completed 6
Reason Not Completed
Adverse Event             1
Physician Decision             1
Protocol Violation             3
Withdrawal by Subject             1
Period Title: Olm 40 mg
Started 182 [1]
Completed 177
Not Completed 5
Reason Not Completed
Adverse Event             2
Protocol Violation             1
Withdrawal by Subject             1
Other             1
[1]
186 -4 met their blood pressure goal (remained on olmesartan 20 mg) = 182
Period Title: Olm 40 mg + Hydrochlorothiazide 12.5 mg
Started 173 [1]
Completed 168
Not Completed 5
Reason Not Completed
Adverse Event             2
Protocol Violation             1
Withdrawal by Subject             1
Other             1
[1]
177 -4 met their blood pressure goal (remained on olmesartan 40 mg)= 173
Period Title: Olm 40 mg + Hydrochlorothiazide 25 mg
Started 144 [1]
Completed 142
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Lost to Follow-up             1
[1]
168 -24 met their blood pressure goal (remained on olmesartan 40 mg/hydrochlorothiazide 12.5mg)= 144
Arm/Group Title Active Treatmant Arm
Hide Arm/Group Description All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
Overall Number of Baseline Participants 192
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 192 participants
58.1  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 192 participants
Female
85
  44.3%
Male
107
  55.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 192 participants
Black/African American 43
Asian 3
White 145
Native Hawaiian/Pacific Islander 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 192 participants
192
Diastolic BP  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 192 participants
90.0  (10.0)
Heart rate  
Mean (Standard Deviation)
Unit of measure:  Beats/min
Number Analyzed 192 participants
76.4  (10.4)
Systolic BP  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 192 participants
158.1  (12.6)
1.Primary Outcome
Title Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.
Hide Description Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 172
Mean (Standard Error)
Unit of Measure: mm Hg
-20.4  (0.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study Population
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No multiplicity adjustments
Method One-sample t-test
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic).
Hide Description Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 172
Mean (Standard Error)
Unit of Measure: mm Hg
Daytime -22.3  (1.05)
Nighttime -18.8  (0.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study Population
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments <0.0001 for both daytime and nighttime. No multiplicity adjustments.
Method one-sample t-test
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 2 Hours of the Last (Week 12) 24-hour Dosing Period.
Hide Description Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM. Of the 172 ABPM participants, only 169 had the required measurements for this outcome analysis.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 169
Mean (Standard Error)
Unit of Measure: mm Hg
-18.6  (1.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study Population
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 4 Hours of the Last (Week 12 ) 24-hour Dosing Period.
Hide Description Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.Of the 172 ABPM participants, only 171 had the required measurements for this outcome analysis.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 171
Mean (Standard Error)
Unit of Measure: mm Hg
-18.2  (1.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study Population
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments No multiplicity adjustments
Method one-sample t-test
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 6 Hours of the Last (Week 12 ) 24-hour Dosing Period.
Hide Description Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM. Of the 172 ABPM participants, only 171 had the required measurements
Arm/Group Title Overall Study Population
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 171
Mean (Standard Error)
Unit of Measure: mm Hg
-18.6  (0.92)
6.Secondary Outcome
Title Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)
Hide Description Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 172
Mean (Standard Error)
Unit of Measure: mm Hg
-11.1  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study Population
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method one-sample t-test
Comments [Not Specified]
7.Secondary Outcome
Title Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12
Hide Description Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 172
Mean (Standard Error)
Unit of Measure: mm Hg
Daytime -12.0  (0.68)
Nighttime -10.2  (0.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study Population
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments <0.0001 applies to both the daytime and nighttime analyses
Method one-sample t-test
Comments [Not Specified]
8.Secondary Outcome
Title Change in Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 During the Last 2 Hours of the Last (Week 12 ) 24-hour Dosing Period.
Hide Description Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
Time Frame baseline and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.Of the 172 participants, only 169 had the required measurements for this outcome analysis.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 169
Mean (Standard Error)
Unit of Measure: mm Hg
-10.6  (0.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study Population
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method one-sample t-test
Comments [Not Specified]
9.Secondary Outcome
Title Change in Ambulatory BP (Diastolic) From Baseline to Week 12 During the Last (Week 12 ) 4 and 6 Hours of the Last 24-hour Dosing Period.
Hide Description Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM. Of the 172 ABPM participants, only 171 had the required measurements for this outcome analysis.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 171
Mean (Standard Error)
Unit of Measure: mm Hg
4 hours -10.7  (0.66)
6 hours -10.8  (0.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study Population
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments <0.0001 applies to both 4 hour and 6 hour analyses
Method one-sample t-test
Comments [Not Specified]
Time Frame 12 week treatment period plus 30 days after the last dose of study medication.
Adverse Event Reporting Description Safety assessments included physical examination, reporting of adverse events, and changes in laboratory values. At each visit, the investigator determined whether any adverse events had occurred by evaluating the subject. Subjects were to be questioned in a general way, without asking about the occurrence of any specific symptoms.
 
Arm/Group Title Olmesartan 20 mg Olmesartan 40 mg Olmesartan 40 mg and Hydrochlorothiazide 12.5 mg Olmesartan 40 mg and Hydrochlorothiazide 25 mg
Hide Arm/Group Description All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled. All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled
All-Cause Mortality
Olmesartan 20 mg Olmesartan 40 mg Olmesartan 40 mg and Hydrochlorothiazide 12.5 mg Olmesartan 40 mg and Hydrochlorothiazide 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Olmesartan 20 mg Olmesartan 40 mg Olmesartan 40 mg and Hydrochlorothiazide 12.5 mg Olmesartan 40 mg and Hydrochlorothiazide 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/192 (0.00%)   0/182 (0.00%)   1/173 (0.58%)   0/144 (0.00%) 
General disorders         
Death due to arteriosclerotic cardiovascular disease  1  0/192 (0.00%)  0/182 (0.00%)  1/173 (0.58%)  0/144 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Olmesartan 20 mg Olmesartan 40 mg Olmesartan 40 mg and Hydrochlorothiazide 12.5 mg Olmesartan 40 mg and Hydrochlorothiazide 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/192 (2.08%)   5/182 (2.75%)   3/173 (1.73%)   6/144 (4.17%) 
Infections and infestations         
Bronchitis  1  3/192 (1.56%)  3/182 (1.65%)  0/173 (0.00%)  0/144 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/192 (0.52%)  2/182 (1.10%)  2/173 (1.16%)  3/144 (2.08%) 
Pain in extremity  1  0/192 (0.00%)  0/182 (0.00%)  1/173 (0.58%)  3/144 (2.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
If identified by Daiichi Sankyo Inc., any of DSI's confidential information, as defined to the author, shall be deleted. Nothing in our site agreement shall be taken as giving Daiichi Sankyo, Inc. any right of editorial control over any publication prepared by the study site.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John J. Raia, R.Ph, Pharm. D.
Organization: Daiichi Sankyo
Phone: 1-877-437-7763
EMail: druginfo@dsus.com
Layout table for additonal information
Responsible Party: William Waverczak, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00403481     History of Changes
Other Study ID Numbers: 866-449
First Submitted: November 22, 2006
First Posted: November 23, 2006
Results First Submitted: November 21, 2008
Results First Posted: September 15, 2009
Last Update Posted: November 3, 2016