Telmisartan and Amlodipine Versus Monocomponent Tablets

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01278797

First received: January 17, 2011

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Results First Received: February 13, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Single Blind; Primary Purpose: Basic Science
Condition:	Hypertension
Interventions:	Drug: Telmisartan/Amlodipine Combination Tablet Drug: Amlodipine Monocomponent

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Telm/Amlo 80 mg/10 mg First, Then Telm 80 mg + Amlo 10 mg	Combination tablet followed by individual components
Telm 80 mg + Amlo 10 mg First, Then Telm/Amlo 80 mg/10 mg	Individual components followed by Combination tablet

Participant Flow for 3 periods

Period 1: Period 1

	Telm/Amlo 80 mg/10 mg First, Then Telm 80 mg + Amlo 10 mg	Telm 80 mg + Amlo 10 mg First, Then Telm/Amlo 80 mg/10 mg
STARTED	14	14
COMPLETED	13	13
NOT COMPLETED	1	1
Adverse Event	0	1
Protocol Violation	1	0

Period 2: Washout Period of 21 Days

	Telm/Amlo 80 mg/10 mg First, Then Telm 80 mg + Amlo 10 mg	Telm 80 mg + Amlo 10 mg First, Then Telm/Amlo 80 mg/10 mg
STARTED	13	13
COMPLETED	13	13
NOT COMPLETED	0	0

Period 3: Period 2

	Telm/Amlo 80 mg/10 mg First, Then Telm 80 mg + Amlo 10 mg	Telm 80 mg + Amlo 10 mg First, Then Telm/Amlo 80 mg/10 mg
STARTED	13	13
COMPLETED	13	13
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Entire Study Population	Includes all subjects randomized to either treatment sequence

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	28
Age [units: years] Mean ± Standard Deviation	39 ± 9
Gender [units: participants]
Female	1
Male	27
Race/Ethnicity, Customized [units: participants]
Hispanic/Latino	7
Asian	3
Black/African American	6
White	12
Height [units: centimeter] Mean ± Standard Deviation	173.1 ± 7.1
Weight [units: kilogram] Mean ± Standard Deviation	80.3 ± 9.9
Body Mass Index [units: kilogram / square meter] Mean ± Standard Deviation	26.7 ± 2.5

Outcome Measures

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1. Primary:

Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72) [ Time Frame: Day 1, Day 22 ]

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2. Primary:

Maximum Observed Plasma Concentration (Cmax) of Amlodipine [ Time Frame: Day 1, Day 22 ]

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3. Secondary:

Time of Maximum Concentration of Amlodipine (TMAX) [ Time Frame: Day 1, Day 22 ]

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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: Other - Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

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: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT01278797 History of Changes
Other Study ID Numbers:	1235.41
Study First Received:	January 17, 2011
Results First Received:	February 13, 2012
Last Updated:	May 18, 2012
Health Authority:	Canada: Health Canada

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