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

• Sponsor: Daiichi Sankyo, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00403481
• Collaborator: (none)
• Enrollment: 192
• Locations: 27
• Arm: 1
• Duration (Months): 13
• Patients Per Site: 7.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with Type II diabetes and high blood pressure. The medication being tested has been approved by the FDA for the treatment of high blood pressure.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: olmesartan medoxomil; Drug: Olmesartan medoxomil plus Hydrochlorothiazide	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 192 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Open Label, Single Arm Study to Evaluate the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen in Type II Diabetic Patients With Hypertension
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Nov 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Active treatment Blood pressure (BP) measurements were taken every three weeks for 12 weeks. In accordance with their BP results, participants either stayed on their current medication or were started on the next higher regimen at the 3, 6, or 9 week visits. All participants began at 20 mg olmesartan, once daily for 3 weeks. The next higher regimen was olmesartan 40 mg, followed by olmesartan 40 mg + 12.5 mg hydrochlorothiazide, followed by olmesartan 40 mg + 25 mg of hydrochlorothiazide.

Drug: olmesartan medoxomil; Olmesartan medoxomil tablets, once daily; Drug: Olmesartan medoxomil plus Hydrochlorothiazide; Olmesartan medoxomil and hydrochlorothiazide combination tablets, once daily, if necessary

Outcome Measures

Primary Outcome Measures

1. Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM. [baseline and 12 weeks]

   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.

Secondary Outcome Measures

1. Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic). [baseline and 12 weeks]

   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.

2. 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. [baseline and 12 weeks]

   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.

3. 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. [baseline and 12 weeks]

   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.

4. 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. [baseline and 12 weeks]

   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.

5. Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic) [baseline and 12 weeks]

   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.

6. Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 [baseline and 12 weeks]

   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.

7. 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. [baseline and 12 Weeks]

   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.

8. 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. [baseline and 12 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients diagnosed with Type II diabetes that are on stable treatment with hypoglycemic agents

• Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mmHg but <200 mmHg and a MSDBP less than or equal to 114 mmHg following a 3 to 4-week single-blind placebo run-in period

• The difference in MSSBP between Visits 3 and 4 or between Visits 4 and 4X must be less than or equal to 10 mmHg

• Patients with a mean daytime (8AM - 4PM) SBP > 130 mmHg and less than or equal to 199 mmHg and a mean daytime DBP less than or equal to 114 as measured by an ambulatory blood pressure monitoring device (ABPM) following placebo run-in period

• If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study

Exclusion Criteria:

• History of stroke or transient ischemic attack (TIA) within the last one year

• History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months

• Presence of overt proteinuria at screening

• Severe hypertension (DBP greater than or equal to 115 mmHg or SBP greater than or equal to 200 mmHg)

• Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome

• Type I or Type II diabetes requiring insulin

• Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease

• Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States
2		Mesa	Arizona	United States
3		Searcy	Arkansas	United States
4		Los Angeles	California	United States
5		Roseville	California	United States
6		Tustin	California	United States
7		Deland	Florida	United States
8		Pembroke Pines	Florida	United States
9		Chicago	Illinois	United States
10		Wichita	Kansas	United States
11		Madisonville	Kentucky	United States
12		Auburn	Maine	United States
13		Baltimore	Maryland	United States
14		Oxon Hill	Maryland	United States
15		Jackson	Mississippi	United States
16		Florissant	Missouri	United States
17		Williamsville	New York	United States
18		Charlotte	North Carolina	United States
19		Winston-Salem	North Carolina	United States
20		Cincinnati	Ohio	United States
21		New Talenwell	Tennessee	United States
22		New Tazewell	Tennessee	United States
23		Colleyville	Texas	United States
24		Corpus Christi	Texas	United States
25		Richardson	Texas	United States
26		Murray	Utah	United States
27		Norfolk	Virginia	United States

Sponsors and Collaborators

• Daiichi Sankyo, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00403481
• Other Study ID Numbers: 866-449
• First Posted: Nov 23, 2006
• Last Update Posted: Nov 3, 2016
• Last Verified: Sep 1, 2016

• Keywords provided by , ,: Hypertension; Angiotensin Receptor Blocker; Calcium Channel Blocker; Angiotensin Converting Enzyme Inhibitor; Hydrochlorothiazide; Stage I and II Hypertension; Type II Diabetes
• Additional relevant MeSH terms: Hypertension; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil

Study Results

Participant Flow

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 Detail	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
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
Period Title: Olmesartan Medoxomil (Olm) 20 mg
STARTED	182
COMPLETED	177
NOT COMPLETED	5
Period Title: Olmesartan Medoxomil (Olm) 20 mg
STARTED	173
COMPLETED	168
NOT COMPLETED	5
Period Title: Olmesartan Medoxomil (Olm) 20 mg
STARTED	144
COMPLETED	142
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Active Treatmant Arm
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 Participants	192
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.1 (10.3)
Sex: Female, Male (Count of Participants)
Female	85 44.3%
Male	107 55.7%
Race/Ethnicity, Customized (Number) [Number]
Black/African American	43 22.4%
Asian	3 1.6%
White	145 75.5%
Native Hawaiian/Pacific Islander	1 0.5%
Region of Enrollment (participants) [Number]
United States	192 100%
Diastolic BP (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	90.0 (10.0)
Heart rate (beats/min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [beats/min]	76.4 (10.4)
Systolic BP (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	158.1 (12.6)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	172
Mean (Standard Error) [mm Hg]	-20.4 (0.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overall Study Population
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	No multiplicity adjustments
	Method	One-sample t-test
	Comments

2. Secondary Outcome

Title	Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic).
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	172
Daytime	-22.3 (1.05)
Nighttime	-18.8 (0.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overall Study Population
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
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

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.
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	169
Mean (Standard Error) [mm Hg]	-18.6 (1.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overall Study Population
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	One-sample t-test
	Comments

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.
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	171
Mean (Standard Error) [mm Hg]	-18.2 (1.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overall Study Population
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments	No multiplicity adjustments
	Method	one-sample t-test
	Comments

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.
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	171
Mean (Standard Error) [mm Hg]	-18.6 (0.92)

6. Secondary Outcome

Title	Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	172
Mean (Standard Error) [mm Hg]	-11.1 (0.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overall Study Population
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	one-sample t-test
	Comments

7. Secondary Outcome

Title	Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	172
Daytime	-12.0 (0.68)
Nighttime	-10.2 (0.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overall Study Population
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
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

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.
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	169
Mean (Standard Error) [mm Hg]	-10.6 (0.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overall Study Population
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	one-sample t-test
	Comments

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.
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	171
4 hours	-10.7 (0.66)
6 hours	-10.8 (0.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overall Study Population
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
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

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/192 (0%)		0/182 (0%)		1/173 (0.6%)		0/144 (0%)
General disorders
Death due to arteriosclerotic cardiovascular disease	0/192 (0%)		0/182 (0%)		1/173 (0.6%)		0/144 (0%)
Other (Not Including 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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/192 (2.1%)		5/182 (2.7%)		3/173 (1.7%)		6/144 (4.2%)
Infections and infestations
Bronchitis	3/192 (1.6%)		3/182 (1.6%)		0/173 (0%)		0/144 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/192 (0.5%)		2/182 (1.1%)		2/173 (1.2%)		3/144 (2.1%)
Pain in extremity	0/192 (0%)		0/182 (0%)		1/173 (0.6%)		3/144 (2.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.