Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

This study has been completed.

Study NCT00430508 Information provided by Daiichi Sankyo Inc.

First Received on February 1, 2007. Last Updated on June 17, 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 and placebo Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets Drug: olmesartan medoxomil/hydrochlorothiazide tablets

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
78 investigative sites screened patients in Europe (19 in Czech Republic, 11 in Germany, 8 in Bulgaria, 5 in Spain, 20 in Ukraine, 1 in France and 14 in Poland). Sites were either hospitals or general practitioners. First patient in: 17 January 2007 Last patient out: 30 March 2008

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

78 investigative sites screened patients in Europe (19 in Czech Republic, 11 in Germany, 8 in Bulgaria, 5 in Spain, 20 in Ukraine, 1 in France and 14 in Poland).

Sites were either hospitals or general practitioners. First patient in: 17 January 2007 Last patient out: 30 March 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. End of Period I, only non-responders randomised to Period II. Blood Pressure controlled patients discontinued. Period II-8-week double-blind four randomized treatment arms. Participant flow is Period II. 972 completed period I, 971 started period II.

Reporting Groups

	Description
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo	olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo	olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo	olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo	olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks

Participant Flow: Overall Study

	OM/HCTZ 40/25mg + 20/12.5 Matching Placebo	OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo	OM/HCTZ 20/12.5mg + 40/0 Matching Placebo	OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
STARTED	140	278	279	274
COMPLETED	137	272	266	269
NOT COMPLETED	3	6	13	5
Adverse Event	2	3	5	3
Withdrawal by Subject	0	1	1	1
responder at visit 4	0	0	2	0
conmed-BP-pulse-ABPM withdrawal criteria	0	1	2	1
not specified	1	1	3	0

Baseline Characteristics

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Reporting Groups

	Description
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo	olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo	olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo	olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo	olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks

Baseline Measures

	OM/HCTZ 40/25mg + 20/12.5 Matching Placebo	OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo	OM/HCTZ 20/12.5mg + 40/0 Matching Placebo	OM/HCTZ 40/0mg + 20/12.5 Matching Placebo	Total
Number of Participants [units: participants]	140	278	279	274	971
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	122	240	233	238	833
>=65 years	18	38	46	36	138
Age [units: years] Mean ± Standard Deviation	55.2 ± 8.17	53.7 ± 9.77	55.2 ± 9.47	54.1 ± 8.92	54.5 ± 9.24
Gender [units: participants]
Female	52	105	100	115	372
Male	88	173	179	159	599
Race/Ethnicity, Customized [units: participants]
European	140	278	278	274	970
Other	0	0	1	0	1

Outcome Measures

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1. Primary:

Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16 [ Time Frame: 8 weeks, change = week 16 - week 8 ]

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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, change = week 12 - week 8 ]

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3. Secondary:

Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16. [ Time Frame: 8 weeks, change = week 16 - week 8 ]

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4. Secondary:

Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12. [ Time Frame: 4 weeks, change = week 12 - week 8 ]

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5. Secondary:

Number of Patients Achieving Target Blood Pressure at Week 16 [ Time Frame: 8 weeks ]

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6. Secondary:

Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16. [ Time Frame: 8 weeks, change = week 16 - week 8 ]

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7. Secondary:

Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16. [ Time Frame: 8 weeks, change = week 16 - week 8 ]

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8. Secondary:

Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16. [ Time Frame: 8 weeks, change = week 16 - week 8 ]

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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
No text entered.

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:	Bettina Ammentorp, Daichi Sankyo Europe, GmbH
ClinicalTrials.gov Identifier:	NCT00430508 History of Changes
Other Study ID Numbers:	CS866CM-B-E301
Study First Received:	February 1, 2007
Results First Received:	February 9, 2009
Last Updated:	June 17, 2009
Health Authority:	EU: EMEA; Germany: Bundesministerium fur; Spain: Ministry of Health; Italy: Ministry of Health; France: Afssaps - French Health Products Safety Agency; Bulgaria: Bulgarian Drug Agency; Ukraine: Ministry of Health; Czech Republic: State Institute for Drug Control; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products