Use of the Combination of Olmesartan and Hydrochlorothiaz... | NCT00430508

NCT00430508

Status Module

Sponsor/Collaborators Module

Name	Class
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
4	Experimental	olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks	Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo
1	Experimental	olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks	Drug: olmesartan medoxomil/hydrochlorothiazide tablets
3	Experimental	olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks	Drug: olmesartan medoxomil/hydrochlorothiazide tablets
2	Experimental	olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks	Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo	Drug	olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16	Change = Week 16 - Week 8 (baseline).	8 weeks, change = week 16 - week 8

Secondary Outcomes

Measure	Description	Time Frame
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.	Change = Week 12 - Week 8 (baseline).	4 weeks, change = week 12 - week 8
Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Professor Lars Christian Rump, M.D.	University of Ruhr-Bochum	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22114906	Derived	Rosenbaum D, Girerd X. Olmesartan medoxomil combined with hydrochlorothiazide improves 24-hour blood pressure control in moderate-to-severe hypertension. Curr Med Res Opin. 2012 Feb;28(2):179-86. doi: 10.1185/03007995.2011.644626. Epub 2012 Jan 9.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	OM/HCTZ 40/25mg + 20/12.5 Matching Placebo	olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks
FG001	OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

No data available

No data is available for this block.

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	OM/HCTZ 40/25mg + 20/12.5 Matching Placebo	olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks
BG001	OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo	olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks
BG002	OM/HCTZ 20/12.5mg + 40/0 Matching Placebo	olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks
BG003	OM/HCTZ 40/0mg + 20/12.5 Matching Placebo	olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00055.2± 8.17 BG00153.7± 9.77 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00052 BG001105 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

European

Title	Measurements
	BG000140 BG001278 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16

Change = Week 16 - Week 8 (baseline).

Full Analysis Set-Last Observation Carried Forward.

Posted

Mean

Standard Deviation

mm Hg

8 weeks, change = week 16 - week 8

ID	Title	Description
OG000	OM/HCTZ 40/25mg + 20/12.5 Matching Placebo	olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
OG001	OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
OG002	OM/HCTZ 20/12.5mg + 40/0 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
OG003	OM/HCTZ 40/0mg + 20/12.5 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Units	Counts
Participants	OG000140 OG001277 OG002279 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-11.16± 8.796 OG001-9.13± 8.622 OG002-8.10± 7.968 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003		ANCOVA		<0.0001		Mean Difference (Net)	-5.3				95	-6.97	-3.6					Superiority or Other
OG001 OG003		ANCOVA		<0.0001

Secondary

Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.

Change = Week 12 - Week 8 (baseline).

Full Analysis Set-Last Observation Carried Forward

Posted

Mean

Standard Deviation

mm Hg

4 weeks, change = week 12 - week 8

ID	Title	Description
OG000	OM/HCTZ 40/25mg + 20/12.5 Matching Placebo	olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
OG001	OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
OG002	OM/HCTZ 20/12.5mg + 40/0 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
OG003	OM/HCTZ 40/0mg + 20/12.5 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Secondary

Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.

Change = Week 16 - Week 8 (baseline).

Full Analysis Set-Last Observation Carried Forward.

Posted

Mean

Standard Deviation

mm Hg

8 weeks, change = week 16 - week 8

ID	Title	Description
OG000	OM/HCTZ 40/25mg + 20/12.5 Matching Placebo	olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
OG001	OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
OG002	OM/HCTZ 20/12.5mg + 40/0 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
OG003	OM/HCTZ 40/0mg + 20/12.5 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Secondary

Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.

Change = Week 12 - Week 8 (baseline).

Full Analysis Set-Last Observation Carried Forward

Posted

Mean

Standard Deviation

mm Hg

4 weeks, change = week 12 - week 8

ID	Title	Description
OG000	OM/HCTZ 40/25mg + 20/12.5 Matching Placebo	olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
OG001	OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
OG002	OM/HCTZ 20/12.5mg + 40/0 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
OG003	OM/HCTZ 40/0mg + 20/12.5 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Secondary

Number of Patients Achieving Target Blood Pressure at Week 16

Target Blood Pressure is diastolic blood pressure (dBP) < 90 mmHg and systolic blood pressure (sBP) < 140 mmHg for non-diabetics, and dBP < 80 mmHg and sBP < 130 mmHg for diabetics

Full Analysis Set-Last Observation Carried Forward

Posted

Number

participants

8 weeks

ID	Title	Description
OG000	OM/HCTZ 40/25mg + 20/12.5 Matching Placebo	olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
OG001	OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
OG002	OM/HCTZ 20/12.5mg + 40/0 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
OG003	OM/HCTZ 40/0mg + 20/12.5 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Secondary

Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.

Change = Week 16 - Week 8 (baseline).

Full Analysis Set-Observed Cases

Posted

Mean

Standard Deviation

mm Hg

8 weeks, change = week 16 - week 8

ID	Title	Description
OG000	OM/HCTZ 40/25mg + 20/12.5 Matching Placebo	olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
OG001	OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
OG002	OM/HCTZ 20/12.5mg + 40/0 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
OG003	OM/HCTZ 40/0mg + 20/12.5 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Secondary

Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.

Change = Week 16 - Week 8 (baseline).

Full Analysis Set-Observed Cases

Posted

Mean

Standard Deviation

mm Hg

8 weeks, change = week 16 - week 8

ID	Title	Description
OG000	OM/HCTZ 40/25mg + 20/12.5 Matching Placebo	olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
OG001	OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
OG002	OM/HCTZ 20/12.5mg + 40/0 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
OG003	OM/HCTZ 40/0mg + 20/12.5 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Secondary

Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.

Change = Week 16 - Week 8 (baseline).

Full Analysis Set-Observed Cases

Posted

Mean

Standard Deviation

mm Hg

8 weeks, change = week 16 - week 8

ID	Title	Description
OG000	OM/HCTZ 40/25mg + 20/12.5 Matching Placebo	olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
OG001	OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
OG002	OM/HCTZ 20/12.5mg + 40/0 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
OG003	OM/HCTZ 40/0mg + 20/12.5 Matching Placebo	olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

ID	Term
D000075222	Essential Hypertension

ID	Term
D000068557	Olmesartan Medoxomil
D006852	Hydrochlorothiazide
D013607	Tablets

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D013777	Tetrazoles
D002740	Chlorothiazide
D001581	Benzothiadiazines
D013449	Sulfonamides
D013450	Sulfones
D013457	Sulfur Compounds
D009930	Organic Chemicals
D049971	Thiazides
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D004304	Dosage Forms
D004364	Pharmaceutical Preparations

Facility	Status	City	State	ZIP	Country	Contacts
		Pleven			Bulgaria

ID	Term
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases