An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination

This study has been completed.

Study NCT00618774 Information provided by Boehringer Ingelheim Pharmaceuticals

First Received on February 8, 2008. Last Updated on March 2, 2010 History of Changes

Results First Received: December 28, 2009

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: telmisartan40/amlodipine5 Drug: telmisartan80/amlodipine5

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
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	No text entered.
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	No text entered.

Participant Flow: Overall Study

	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
STARTED	211	48
COMPLETED	205	45
NOT COMPLETED	6	3
Adverse Event	5	3
Withdrawal by Subject	1	0

Baseline Characteristics

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Reporting Groups

	Description
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	No text entered.
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	No text entered.

Baseline Measures

	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Total
Number of Participants [units: participants]	211	48	259
Age [units: Years] Mean ± Standard Deviation	56.8 ± 9	51.1 ± 8	55.8 ± 9
Gender [units: participants]
Female	50	4	54
Male	161	44	205

Outcome Measures

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1. Primary:

Percentage of Participants Who Experienced Adverse Events [ Time Frame: 52 weeks ]

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2. Secondary:

Change From Baseline in Seated Diastolic Blood Pressure at Week 8 [ Time Frame: Baseline and week 8 ]

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3. Secondary:

Change From Baseline in Seated Systolic Blood Pressure at Week 8 [ Time Frame: Baseline and week 8 ]

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4. Secondary:

Change From Baseline in Seated Diastolic Blood Pressure at Week 48 [ Time Frame: Baseline and week 48 ]

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5. Secondary:

Change From Baseline in Seated Systolic Blood Pressure at Week 48 [ Time Frame: Baseline and week 48 ]

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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: 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:	NCT00618774 History of Changes
Other Study ID Numbers:	1235.16
Study First Received:	February 8, 2008
Results First Received:	December 28, 2009
Last Updated:	March 2, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare