Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension

This study has been completed.

Study NCT00553267 Information provided by Boehringer Ingelheim Pharmaceuticals

First Received on October 8, 2007. Last Updated on January 20, 2010 History of Changes

Results First Received: November 18, 2009

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: fixed dose combination of 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
Amlodipine 10mg	No text entered.
Telmisartan 40mg and Amlodipine 10mg	No text entered.
Telmisartan 80mg and Amlodipine 10mg	No text entered.

Participant Flow: Overall Study

	Amlodipine 10mg	Telmisartan 40mg and Amlodipine 10mg	Telmisartan 80mg and Amlodipine 10mg
STARTED	315	315	317
COMPLETED	301	297	307
NOT COMPLETED	14	18	10
Adverse Event	8	10	5
Non compliant with protocol	3	3	2
Lost to Follow-up	0	0	1
Consent withdrawn	2	3	1
Specified category	1	2	1

Baseline Characteristics

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Reporting Groups

	Description
Amlodipine 10mg	No text entered.
Telmisartan 40mg and Amlodipine 10mg	No text entered.
Telmisartan 80mg and Amlodipine 10mg	No text entered.

Baseline Measures

	Amlodipine 10mg	Telmisartan 40mg and Amlodipine 10mg	Telmisartan 80mg and Amlodipine 10mg	Total
Number of Participants [units: participants]	315	315	317	947
Age [units: Years] Mean ± Standard Deviation	56.4 ± 10.4	57.6 ± 9.4	55.5 ± 9.8	56.5 ± 9.9
Gender [units: Number of participants]
Female	128	145	146	419
Male	187	170	171	528

Outcome Measures

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1. Primary:

Change From Baseline in Trough Seated Diastolic Blood Pressure [ Time Frame: Baseline and end of study (8 weeks or last value on treatment) ]

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2. Secondary:

Change From Baseline in Trough Seated Systolic Blood Pressure [ Time Frame: Baseline and end of study (8 weeks or last value on treatment) ]

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3. Secondary:

Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg) [ Time Frame: End of study (8 weeks or last value on treatment) ]

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4. Secondary:

Trough Seated Diastolic Blood Pressure <80 mmHg [ Time Frame: End of study (8 weeks or last value on treatment) ]

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5. Secondary:

Trough Seated DBP Response [ Time Frame: End of study (8 weeks or last value on treatment) ]

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6. Secondary:

Trough Seated SBP Control [ Time Frame: End of study (8 weeks or last value on treatment) ]

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7. Secondary:

Trough Seated SBP Response [ Time Frame: End of study (8 weeks or last value on treatment) ]

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8. Secondary:

Trough Seated BP Normality Classes [ Time Frame: End of study (8 weeks or last value on treatment) ]

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9. Secondary:

Oedema Incidence Rate [ Time Frame: During randomised treatment period ]

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10. Secondary:

Peripheral Oedema Incidence Rate [ Time Frame: During randomised treatment period ]

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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:	NCT00553267 History of Changes
Other Study ID Numbers:	1235.6, EUDRACT 2007-002421-68
Study First Received:	October 8, 2007
Results First Received:	November 18, 2009
Last Updated:	January 20, 2010
Health Authority:	Australia: Responsilble Ethics Committee; Austria: Federal Office for Safety in Health Care; Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia; Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; Great Britain: MHRA; Ireland: Irish Medicines Board; Italy: Comitato Etico della provinciale di Ferrara; New Zealand: Multicentre Ethics Committee/Medsafe; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26; Spain: Agencia Española del Medicamento y Productos Sanitarios; Switzerland: Swissmedic, Hallerstrasse 7, 3000 Bern; Turkey: Ministry of Health Central Ethics Committee; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)