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A Study of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Stage I and Stage II Hypertension

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ClinicalTrials.gov Identifier: NCT00430638
Recruitment Status : Completed
First Posted : February 2, 2007
Results First Posted : January 22, 2010
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary
Drug: Placebo
Enrollment 278
Recruitment Details Subjects were recruited at 29 US sites (private medical practices and small clinics) over 5 months from December 2006 to May 2007 from each physician's clientele base. About 450 potential subjects were to be screened so that about 250 eligible subjects, men and women at least 18 years of age with stage I or II hypertension, were randomized.
Pre-assignment Details After 3-4 weeks of placebo treatment, eligible subjects were randomized. 140 were randomized to drug; 138 to placebo. 2 active drug participants were given the wrong dose at entry. Because only 138 participants received Olmesartan 20 mg, any demography data totals are equal to 276 instead of 278. The subgroup analyses are similarly affected.
Arm/Group Title Placebo (Pbo) Group Olmesartan Group
Hide Arm/Group Description 138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg. 140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg.
Period Title: Overall Study
Started 138 140 [1]
Completed 60 92
Not Completed 78 48
Reason Not Completed
Adverse Event             15             15
Uncontrolled blood pressure             48             13
Lost to Follow-up             1             7
Protocol Violation             6             4
Withdrawal by Subject             4             6
Non-compliant             2             1
Not specified             2             2
[1]
2 participants were erroneously assigned to olmesartan 40 mg instead of 20 mg
Arm/Group Title Olmesartan Group Placebo Group Total
Hide Arm/Group Description Participants were randomized to an olmesartan (Olm) based active treatment group. After 3,6,and 9 weeks of treatment participants were titrated to the next regiment if their blood pressure was greater than 120/80 mmHg. The active treatment group received olm 20 mg (weeks 1-3), olm 40 mg (weeks 4-6), olm 40 mg + 12.5 mg hydrchlorothiazide (HCTZ) (weeks 7-9), and olm 40 mg + 25 mg HCTZ (weeks 10-12). Participants were randomized to a placebo (Pbo) group. The Pbo participants remained in the pbo group for the entire 12 weeks of treatment. Total of all reporting groups
Overall Number of Baseline Participants 138 138 276
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 138 participants 138 participants 276 participants
55.9
(26 to 86)
55.8
(35 to 80)
55.9
(26 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 138 participants 276 participants
Female
75
  54.3%
72
  52.2%
147
  53.3%
Male
63
  45.7%
66
  47.8%
129
  46.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 138 participants 138 participants 276 participants
138 138 276
Diastolic BP  
Mean (Full Range)
Unit of measure:  Mm Hg
Number Analyzed 138 participants 138 participants 276 participants
94.2
(74 to 106)
93.7
(69 to 107)
94.0
(69 to 107)
Heart Rate  
Mean (Full Range)
Unit of measure:  Beats/minute
Number Analyzed 138 participants 138 participants 276 participants
75.1
(52 to 122)
73.6
(47 to 94)
74.4
(47 to 122)
Systolic BP  
Mean (Full Range)
Unit of measure:  Mm Hg
Number Analyzed 138 participants 138 participants 276 participants
156.9
(140 to 178)
155.4
(136 to 178)
156.2
(136 to 178)
1.Primary Outcome
Title Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.
Hide Description The change from baseline in mean systolic blood pressure (SBP) after 12 weeks of randomized treatment was compared between the olmesartan based treatment group and the placebo treatment group.
Time Frame baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy cohort is defined as any subject who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline efficacy blood pressure assessment. 140 participants were originally randomized to the olmesartan group. 139 is the correct number analyzed. For the placebo group the efficacy cohort = 137.
Arm/Group Title Placebo Olmesartan Group
Hide Arm/Group Description:
Patient received placebo tablets.
Participants received olmesatan medoxomil plus hydrochlorothiazide, if necessary.
Overall Number of Participants Analyzed 137 139
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-0.1  (1.40) -22.3  (1.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Olmesartan Group
Comments Null hypothesis: For the entire efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No multiplicity adjustments
Method ANCOVA
Comments The ANCOVA model included randomized treatment and baseline cuff blood pressure stage as factors and study baseline systolic BP value as a covariate.
2.Secondary Outcome
Title Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.
Hide Description Change from study baseline (average of triplicate DBP measurements at the last 2 qualifying visits during placebo run-in period) in DBP to the end of 12 weeks of randomized treatment using a last observation carried forward (LOCF) approach.
Time Frame baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy cohort is defined as any subject who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline efficacy blood pressure assessment. 140 participants were originally randomized to the olmesartan group, but two were erroneously started with the 40mg dose. 139 is the correct number analyzed.
Arm/Group Title Placebo Group Olmesartan Group
Hide Arm/Group Description:
Patient received placebo tablets throughout the 12-week active treatment period.
Participants received olmesartan medoxomil tablets + hydrochlorothiazide tablets, if necessary, once daily for the duration of the 12-week active treatment period.
Overall Number of Participants Analyzed 137 139
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-0.8  (0.78) -12.1  (0.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Group, Olmesartan Group
Comments Null hypothesis: For the entire efficacy population, Olmesartan had the same effect on change from baseline in diastolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments The ANCOVA Model included randomized treatment and baseline cuff BP stage as factors and study baseline diastolic BP as a covariate.
3.Secondary Outcome
Title The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Males.
Hide Description The difference in the change from baseline to week 12 in seated systolic and diastolic blood pressure for males in the olmesartan group vs. the placebo group was analyzed.
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
131 male participants
Arm/Group Title Olmesartan vs. Placebo
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 131
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
Systolic Blood Pressure -22.6  (2.94)
Diastolic Blood Pressure -13.5  (1.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan vs. Placebo
Comments Null hypothesis (male systolic blood pressure (SBP)): For the male efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olmesartan vs. Placebo
Comments Null hypothesis (Males - diastolic blood pressure (DBP)): For the male efficacy population, Olmesartan had the same effect on change from baseline in diastolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Females.
Hide Description The difference in the change from baseline to week 12 in seated blood pressure for females in the olmesartan group vs. the placebo group was analyzed.
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
145 female participants from both the olmesartan and placebo groups were analyzed.
Arm/Group Title Olmesartan vs. Placebo
Hide Arm/Group Description:
145 females participants were analyzed.
Overall Number of Participants Analyzed 145
Least Squares Mean (Standard Deviation)
Unit of Measure: mm Hg
Systolic blood pressure -21.6  (2.6)
Diastolic blood pressure -12.0  (1.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan vs. Placebo
Comments Null hypothesis (Systolic blood pressure (SBP) - females): For the female efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olmesartan vs. Placebo
Comments Null hypothesis (Diastolic blood pressure (DBP) - females): For the female efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Less Than 65 Years Old.
Hide Description [Not Specified]
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
232 participants from both the olmesartan and placebo groups, less than 65 years of age, were analyzed.
Arm/Group Title Olmesartan vs. Placebo
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 232
Least Squares Mean (Standard Deviation)
Unit of Measure: mm Hg
Systolic blood pressure -23.8  (2.04)
Diastolic blood pressure -13.6  (1.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan vs. Placebo
Comments Null hypothesis(Systolic blood pressure (SBP) - less than 65 years of age): For the efficacy population < 65 years of age, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olmesartan vs. Placebo
Comments Null hypothesis (Diastolic blood pressure (DBP) - less than 65 years of age): For the efficacy population < 65 years of age, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Greater Than or Equal to 65 Years Old.
Hide Description [Not Specified]
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
44 participants of greater than 65 years of age, from both the olmesartan and placebo groups were analyzed.
Arm/Group Title Olmesartan vs. Placebo
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 44
Least Squares Mean (Standard Deviation)
Unit of Measure: mm Hg
Systolic blood pressure -16.1  (6.18)
Diastolic blood pressure -9.0  (2.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan vs. Placebo
Comments Null hypothesis (Systolic blood pressure (SBP) - > or equal to 65 years old): For the efficacy population > or = to 65 years of age, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0125
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olmesartan vs. Placebo
Comments Null hypothesis (Diastolic blood pressure (DBP) > or equal to 65): For the efficacy population > or = to 65 years of age, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Black Participants.
Hide Description [Not Specified]
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
55 Black participants from both the olmesartan and placebo groups were analyzed.
Arm/Group Title Olmesartan vs. Placebo
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 55
Least Squares Mean (Standard Deviation)
Unit of Measure: mm Hg
Systolic blood pressure -21.3  (4.97)
Diastolic blood pressure -12.5  (2.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan vs. Placebo
Comments Null hypothesis (Systolic blood pressure (SBP) - Black participants): For the Black efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olmesartan vs. Placebo
Comments Null hypothesis (Diastolic blood pressure (DBP) - Black participants): For the Black efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Non-Black Participants.
Hide Description [Not Specified]
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
221 non-Black participants from both the olmesartan and placebo groups were analyzed.
Arm/Group Title Olmesartan vs. Placebo
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 221
Least Squares Mean (Standard Deviation)
Unit of Measure: mm Hg
Systolic blood pressure -22.3  (2.14)
Diastolic blood pressure -12.8  (1.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan vs. Placebo
Comments Null hypothesis(Systolic blood pressure (SBP) - non-Black participants): For the Non-Black efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olmesartan vs. Placebo
Comments Null hypothesis(Diastolic blood pressure (DBP) - non-Black participants): For the Non-Black efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
9.Secondary Outcome
Title The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 1 Hypertensives
Hide Description [Not Specified]
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
130 Stage 1 hypertensive participants from both the olmesartan and placebo groups.
Arm/Group Title Olmesartan vs. Placebo
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 130
Least Squares Mean (Standard Deviation)
Unit of Measure: mm Hg
Systolic blood pressure -22.1  (2.43)
Diastolic blood pressure -12.2  (1.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan vs. Placebo
Comments Null hypothesis(Systolic blood pressure (SBP) - Stage 1 hypertensive participants): For the Stage 1 efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olmesartan vs. Placebo
Comments Null hypothesis (Diastolic blood pressure (DBP) - Stage 1 hypertensive participants): For the Stage 1 efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
10.Secondary Outcome
Title The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 2 Hypertensives
Hide Description [Not Specified]
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
146 Stage 2 hypertensive participants from both the olmesartan and placebo groups
Arm/Group Title Olmesartan vs. Placebo
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 146
Least Squares Mean (Standard Deviation)
Unit of Measure: mm Hg
Systolic blood pressure -22.5  (3.07)
Diastolic blood pressure -13.2  (1.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan vs. Placebo
Comments Null hypothesis (Systolic blood pressure (SBP) - Stage 2 hypertensive participants): For the Stage 2 efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olmesartan vs. Placebo
Comments Null hypothesis (Diastolic blood pressure (DBP) - Stage 2 hypertensive participants): For the Stage 2 efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame 12-week randomized, treatment period plus 30 days after the last dose of study medication.
Adverse Event Reporting Description All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.
 
Arm/Group Title Placebo (Pbo) Group Olmesartan Group
Hide Arm/Group Description 138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg. 140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg.
All-Cause Mortality
Placebo (Pbo) Group Olmesartan Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Pbo) Group Olmesartan Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/138 (0.00%)   3/140 (2.14%) 
Cardiac disorders     
Supraventricular tachycardia  1  0/138 (0.00%)  1/140 (0.71%) 
Gastrointestinal disorders     
Small Intestine Obstruction  1  0/138 (0.00%)  1/140 (0.71%) 
Vascular disorders     
Hypertension  1  0/138 (0.00%)  1/140 (0.71%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo (Pbo) Group Olmesartan Group
Affected / at Risk (%) Affected / at Risk (%)
Total   46/138 (33.33%)   55/140 (39.29%) 
Immune system disorders     
Seasonal allergy  1  2/138 (1.45%)  3/140 (2.14%) 
Infections and infestations     
Upper respiratory tract infection  1  7/138 (5.07%)  9/140 (6.43%) 
Urinary tract infection  1  0/138 (0.00%)  4/140 (2.86%) 
Viral upper respiratory infection  1  7/138 (5.07%)  1/140 (0.71%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  4/138 (2.90%)  8/140 (5.71%) 
Nervous system disorders     
Dizziness  1  1/138 (0.72%)  13/140 (9.29%) 
Headache  1  17/138 (12.32%)  11/140 (7.86%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  7/138 (5.07%)  3/140 (2.14%) 
Vascular disorders     
Hypertension  1  1/138 (0.72%)  3/140 (2.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
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.(DSI), any of DSI's confidential information, as defined to the author, shall be deleted. Nothing in our site agreement shall be taken as giving DSI 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: Global Clinical Leader
Organization: Daiichi Sankyo
Phone: 1-908-992-6400
Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00430638     History of Changes
Other Study ID Numbers: 866-451
First Submitted: February 1, 2007
First Posted: February 2, 2007
Results First Submitted: October 3, 2008
Results First Posted: January 22, 2010
Last Update Posted: October 2, 2018