Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

This study has been completed.

Study NCT00430950 Information provided by Daiichi Sankyo Inc.

First Received on February 1, 2007. Last Updated on April 29, 2009 History of Changes

Results First Received: February 9, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Essential Hypertension
Interventions:	Drug: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets Drug: olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
92 principal investigators screened patients at clinical sites in Europe (8 in Belgium, 17 in Germany, 12 in the Netherlands, 17 in Poland, 19 in Russia, 10 in Slovakia, and 9 in the Ukraine).Sites were either hospitals or general practitioners. First patient in: 05 December 2006 Last patient out: 07 May 2008

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

92 principal investigators screened patients at clinical sites in Europe (8 in Belgium, 17 in Germany, 12 in the Netherlands, 17 in Poland, 19 in Russia, 10 in Slovakia, and 9 in the Ukraine).Sites were either hospitals or general practitioners.

First patient in: 05 December 2006 Last patient out: 07 May 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Trial is 2 week taper-off phase and 2 treatment periods. Period I - 8-week open-label OM 40mg. Only non-responders eligible to randomise into Period II. Period II - 8-week double-blind patients assigned into one of two arms. Results provided for Period II only.

Reporting Groups

	Description
OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo	Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo	Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo

Participant Flow: Overall Study

	OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo	OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
STARTED	502	508
COMPLETED	489	495
NOT COMPLETED	13	13
Adverse Event	7	6
Withdrawal by Subject	1	0
concomitant medication,etc.	5	7

Baseline Characteristics

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Reporting Groups

	Description
OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo	Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo	Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo

Baseline Measures

	OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo	OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo	Total
Number of Participants [units: participants]	502	508	1010
Age [units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	404	422	826
>=65 years	93	75	168
>= 75 years	5	11	16
Age [units: years] Mean ± Standard Deviation	54.7 ± 9.67	54.4 ± 9.77	54.6 ± 9.72
Gender [units: participants]
Female	194	201	395
Male	308	307	615
Race/Ethnicity, Customized [units: participants]
European	502	508	1010

Outcome Measures

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1. Primary:

Change in Mean Trough Sitting Diastolic Blood Pressure [ Time Frame: 8 weeks ]

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2. Secondary:

Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12 [ Time Frame: 4 weeks ]

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3. Secondary:

Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline. [ Time Frame: 8 weeks ]

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4. Secondary:

Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline. [ Time Frame: 8 weeks ]

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5. Secondary:

Number of Participants Achieving Blood Pressure Goal. [ Time Frame: 8 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Results of Study shall not be published without prior express written consent and approval of Sponsor. If Contractor wishes to use data generated at Sites by Investigator, such data includes but not limited to data used in collection of metrics, copy of any intended publication, details of use must be sent in writing to Quintiles and Sponsor for review. Sponsor has right to change proposed publication and/or prohibit publication and Contractor must comply with requirements of Sponsor

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: James McCarthy Director Regulatory Operations
Organization: Daiichi Sankyo
phone: 732-590-3430
e-mail: jmccarthy@dsus.com

No publications provided

Responsible Party:	Dr. Bettina Ammentorp, Daichi Sankyo Europe, GmbH
ClinicalTrials.gov Identifier:	NCT00430950 History of Changes
Other Study ID Numbers:	CS866CM-B-E302
Study First Received:	February 1, 2007
Results First Received:	February 9, 2009
Last Updated:	April 29, 2009
Health Authority:	EU: EMEA; Germany: Bundesministerium fur Gesundeheit und Soziale Sicherung; The Netherlands: Staatstoezicht op de volksgezondheid; Ukraine: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation; Slovakia: State Institute for Drug Control; Belgium: Directorate general for the protection of Public health: Medicines; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products