Filtered Trial for Amlodipine Non-responder

This study has been completed.

Study NCT00558064 Information provided by Boehringer Ingelheim Pharmaceuticals

First Received on October 29, 2007. Last Updated on February 8, 2010 History of Changes

Results First Received: November 10, 2009

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: telmisartan+amlodipine Drug: amlodipine

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	T40/A5 tablet, oral, once daily in the morning
Amlodipine 5 mg Monotherapy	A5 capsule, oral, once daily in the morning

Participant Flow: Overall Study

	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Amlodipine 5 mg Monotherapy
STARTED	269	262
COMPLETED	264	257
NOT COMPLETED	5	5
Adverse Event	3	2
Lack of Efficacy	0	1
Protocol Violation	1	0
Lost to Follow-up	0	1
Withdrawal by Subject	0	1
No visit within allowance period	1	0

Baseline Characteristics

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Reporting Groups

	Description
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	T40/A5 tablet, oral, once daily in the morning
Amlodipine 5 mg Monotherapy	A5 capsule, oral, once daily in the morning

Baseline Measures

	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Amlodipine 5 mg Monotherapy	Total
Number of Participants [units: participants]	269	262	531
Age [units: years] Mean ± Standard Deviation	57 ± 9.6	56 ± 9.9	56.5 ± 9.7
Gender [units: participants]
Female	72	76	148
Male	197	186	383

Outcome Measures

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1. Primary:

Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks [ Time Frame: Baseline and 8 Weeks ]

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2. Secondary:

Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks [ Time Frame: Baseline and 8 Weeks ]

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3. Secondary:

Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]

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4. Secondary:

Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]

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5. Secondary:

Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]

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6. Secondary:

Percentage of Patients Who Achieved an Adequate Response, Defining Seated Trough Systolic Blood Pressure Was <140 mmHg or Decreased From Reference Baseline by >=20 mmHg at 8 Weeks in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]

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7. Secondary:

Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]

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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:	NCT00558064 History of Changes
Other Study ID Numbers:	1235.13
Study First Received:	October 29, 2007
Results First Received:	November 10, 2009
Last Updated:	February 8, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare