Olmesartan Comparison to Losartan in Hypertensive Subjects

This study has been completed.

Study NCT00949884 Information provided by Daiichi Sankyo Inc.

First Received on July 29, 2009. Last Updated on March 7, 2011 History of Changes

Results First Received: January 31, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: olmesartan medoxomil Drug: Placebo Drug: losartan potassium

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
Participants were enrolled at 119 out-patient centers throughout the U.S.: 1976 patients were screened, 1632 were enrolled, and 941 randomized.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to group assignment was a 2-9 day screening period and a 3-4 week single-blind (participant was blinded) placebo run-in period. Participants were randomized in an 8:1:9 ratio to treatment arms as listed.

Reporting Groups

	Description
Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Placebo Followed by Olmesartan	Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
Losartan	Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks

Participant Flow: Overall Study

	Olmesartan	Placebo Followed by Olmesartan	Losartan
STARTED	420	52	469
COMPLETED	370	37	411
NOT COMPLETED	50	15	58
Adverse Event	14	3	12
Did not meet inclusion/exclusion	2	1	3
Lost to Follow-up	7	5	5
Physician Decision	5	0	6
Treatment non-compliance	5	0	8
Withdrawal by Subject	13	4	16
Lack of Efficacy	4	2	7
Study terminated by sponsor	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Placebo Followed by Olmesartan	Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
Losartan	Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks

Baseline Measures

	Olmesartan	Placebo Followed by Olmesartan	Losartan	Total
Number of Participants [units: participants]	420	52	469	941
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	385	51	423	859
>=65 years	35	1	46	82
Age [units: years] Mean ± Standard Deviation	52.0 ± 9.84	49.9 ± 8.67	52.1 ± 9.76	51.9 ± 9.74
Gender [units: participants]
Female	190	27	211	428
Male	230	25	258	513
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	52	7	61	120
Not Hispanic or Latino	368	45	408	821
Unknown or Not Reported	0	0	0	0
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	4	0	2	6
Asian	25	2	26	53
Native Hawaiian or Other Pacific Islander	0	0	2	2
Black or African American	118	16	133	267
White	273	33	304	610
More than one race	0	0	0	0
Unknown or Not Reported	0	1	2	3
Hypertension stage ^[1] [units: participants]
Stage I	120	23	134	277
Stage II	300	29	335	664
Height [units: centimeter] Mean ± Standard Deviation	169.92 ± 9.635	169.46 ± 9.652	170.47 ± 9.906	170.17 ± 9.767
Weight [units: kilogram] Mean ± Standard Deviation	93.73 ± 19.627	96.14 ± 22.611	94.02 ± 21.647	94.01 ± 20.810
Body Mass Index [units: kilogram/meter^2] Mean ± Standard Deviation	32.41 ± 6.089	33.62 ± 8.103	32.28 ± 6.619	32.41 ± 6.480
Systolic Blood Pressure [units: mmHg] Mean ± Standard Deviation	158.3 ± 10.41	157.9 ± 10.05	158.3 ± 10.24	158.3 ± 10.29
Diastolic Blood Pressure [units: mmHg] Mean ± Standard Deviation	101.1 ± 4.07	100.8 ± 3.79	101.3 ± 4.14	101.2 ± 4.09
Pulse Rate [units: beats per minute] Mean ± Standard Deviation	78.8 ± 11.41	81.9 ± 9.88	78.5 ± 10.59	78.9 ± 10.94

[1]	Hypertension stage was calculated using the baseline mean BP value. Stage I = systolic blood pressure of 140-159 mmHg and diastolic blood pressure 90-99 mmHg, Stage II = systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg

Outcome Measures

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1. Primary:

Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) [ Time Frame: Day 0, Week 8 ]

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2. Secondary:

Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) [ Time Frame: Day 0, Week 4 ]

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3. Secondary:

Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) [ Time Frame: Day 0, Week 8 ]

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4. Secondary:

Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) [ Time Frame: Day 0, Week 4 ]

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5. Post-Hoc:

Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8 [ Time Frame: Week 8 ]

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6. Other Pre-specified:

Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) [ Time Frame: Week 4, Week 8 ]

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7. Other Pre-specified:

Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) [ Time Frame: Week 4, Week 8 ]

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8. Other Pre-specified:

Percentage of Participants Achieving Blood Pressure Goals at Week 4 [ Time Frame: Week 4 ]

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9. Other Pre-specified:

Percentage of Participants Achieving Blood Pressure Goals at Week 8 [ Time Frame: Week 8 ]

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10. Other Pre-specified:

Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4 [ Time Frame: Baseline, Week 4 ]

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11. Other Pre-specified:

Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8 [ Time Frame: Baseline, Week 8 ]

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12. Other Pre-specified:

Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4 [ Time Frame: Baseline, Week 4 ]

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13. Other Pre-specified:

Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8 [ Time Frame: Baseline, Week 8 ]

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14. Other Pre-specified:

Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 [ Time Frame: Baseline, Week 4 ]

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15. Other Pre-specified:

Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 [ Time Frame: Baseline, Week 8 ]

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16. Other Pre-specified:

Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure [ Time Frame: Baseline, Week 2 ]

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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: Sponsor reflects the following restrictive language in the Clinical Study Agreements: "If identified by DSI, any of DSI's confidential information as defined herein shall be deleted…Nothing in this publication section shall be taken as giving DSI any right of editorial control over any publication prepared by the Study Site."

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: Robert Dubiel, PharmD
Organization: Daiichi Sankyo, Inc.
phone: 973-944-2963
e-mail: bdubiel@dsi.com

No publications provided

Responsible Party:	Director, Medical Affairs, Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier:	NCT00949884 History of Changes
Other Study ID Numbers:	CS0866-A-U452
Study First Received:	July 29, 2009
Results First Received:	January 31, 2011
Last Updated:	March 7, 2011
Health Authority:	United States: Food and Drug Administration