Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension

This study has been completed.

Study NCT00649389 Information provided by Daiichi Sankyo Inc.

First Received on March 28, 2008. Last Updated on August 31, 2010 History of Changes

Results First Received: August 9, 2010

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:	Hypertension
Interventions:	Drug: Olmesartan medoxomil Drug: Amlodipine Drug: Hydrochlorothiazide

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
First subject first visit 12 May 2008. Last subject last follow-up 27 Feb 2009. 317 sites in USA and Puerto Rico. Planned: 2400 subjects (600 per treatment arm). Enrolled: 6724 subjects. Randomized: 2492 subjects.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Duration of the study was 57 weeks with 52 weeks of treatment. This included 3-week stabilization/washout (Period I), 12-week double blind treatment (Period II), 40 week open label treatment (Period III), and 2-week post treatment follow-up (Period IV).

Reporting Groups

	Description
OM40/AML10	Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
OM40/HCTZ25	Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
AML10/HCTZ25	Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
OM40/AML10/HCTZ25	Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.

Participant Flow: Overall Study

	OM40/AML10	OM40/HCTZ25	AML10/HCTZ25	OM40/AML10/HCTZ25
STARTED	628	637	600	627
COMPLETED	557	531	512	516
NOT COMPLETED	71	106	88	111
Adverse Event	22	46	38	48
Lost to Follow-up	15	17	21	26
Protocol Violation	11	13	9	8
Withdrawal by Subject	20	21	19	23
unknown	3	9	1	6

Baseline Characteristics

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Reporting Groups

	Description
OM40/AML10	Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
OM40/HCTZ25	Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
AML10/HCTZ25	Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
OM40/AML10/HCTZ25	Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.

Baseline Measures

	OM40/AML10	OM40/HCTZ25	AML10/HCTZ25	OM40/AML10/HCTZ25	Total
Number of Participants [units: participants]	628	637	600	627	2492
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	508	505	504	504	2021
>=65 years	120	132	96	123	471
Age [units: years] Mean ± Standard Deviation	55.1 ± 10.93	55.9 ± 10.78	54.6 ± 10.82	54.7 ± 11.22	55.1 ± 10.94
Gender [units: participants]
Female	303	298	266	307	1174
Male	325	339	334	320	1318
Race/Ethnicity, Customized ^[1] [units: Participants]
American Indian/Alaskan Native	3	1	4	1	9
Asian	13	10	7	19	49
Hawaiian/Pacific Islander	0	1	1	2	4
Black/African American	181	200	192	184	757
White	431	421	391	415	1658
Unknown or Not Reported	0	4	5	6	15
Diabetes Status [units: Participants]
Diabetic	100	99	92	96	387
Not diabetic	528	538	508	531	2105
Weight [units: kg] Mean ± Standard Deviation	95.9 ± 22.65	96.1 ± 22.55	96.1 ± 23.41	96.0 ± 23.24	96.0 ± 22.94
Body Mass Index [units: Participants]
Less than 30 kg/m2	229	238	230	240	937
Greater than or equal to 30 kg/m2	399	399	370	387	1555
Duration of hypertension [units: years] Mean ± Standard Deviation	10.12 ± 9.865	10.34 ± 9.826	9.73 ± 8.983	9.54 ± 9.558	9.94 ± 9.571

[1]	Race of participants as selected by participant. Participants were allowed to choose more than one race category; therefore, the total for an arm may be greater than the number of participants

Outcome Measures

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1. Primary:

Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). [ Time Frame: baseline to 12 weeks ]

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2. Secondary:

Percentage of Subjects Who Reached Blood Pressure Goal (<140/90 mmHg; <130/80 mmHg for Subjects With Diabetes, Chronic Renal Disease, or Chronic Cardiovascular Disease)by 12 Weeks [ Time Frame: Baseline to 12 weeks ]

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3. Secondary:

Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination [ Time Frame: Baseline to 12 weeks or early termination ]

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4. Secondary:

Change in Seated Systolic Blood Pressure From Baseline to Week 12 [ Time Frame: Baseline to week 12 ]

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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: Study site may not publish results of study until after coordinated multicenter publication has been submitted for publication or one year after study has ended, whichever occurs first. Therefore, study site will have the opportunity to publish results of study, provided that Daiichi Sankyo has had the opportunity to review and comment on study site’s proposed publication prior to being submitted for publication with advice of company patent council and in accord with subject protection needs.

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: Howard Kessler
Organization: Daiichi Sankyo
phone: 732-590-5032
e-mail: hmkessler@dsi.com

No publications provided by Daiichi Sankyo Inc.

Publications automatically indexed to this study:

Oparil S, Melino M, Lee J, Fernandez V, Heyrman R. Triple therapy with olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide in adult patients with hypertension: The TRINITY multicenter, randomized, double-blind, 12-week, parallel-group study. Clin Ther. 2010 Jul;32(7):1252-69.

Chrysant SG, Oparil S, Melino M, Karki S, Lee J, Heyrman R. Efficacy and safety of long-term treatment with the combination of amlodipine besylate and olmesartan medoxomil in patients with hypertension. J Clin Hypertens (Greenwich). 2009 Sep;11(9):475-82.

Responsible Party:	Executive Director Clinical Development, Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00649389 History of Changes
Other Study ID Numbers:	CS8635-A-U301
Study First Received:	March 28, 2008
Results First Received:	August 9, 2010
Last Updated:	August 31, 2010
Health Authority:	United States: Food and Drug Administration