Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension

This study has been completed.

Study NCT00558428 Information provided by Boehringer Ingelheim Pharmaceuticals

First Received on October 29, 2007. Last Updated on July 4, 2011 History of Changes

Results First Received: November 13, 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
1487 were enrolled, 1098 entered but 1 patient not treated.

Reporting Groups

	Description
Amlodipine 5mg	No text entered.
Amlodipine 10mg	No text entered.
Telmisartan 40mg and Amlodipine 5mg	No text entered.
Telmisartan 80mg and Amlodipine 5mg	No text entered.

Participant Flow: Overall Study

	Amlodipine 5mg	Amlodipine 10mg	Telmisartan 40mg and Amlodipine 5mg	Telmisartan 80mg and Amlodipine 5mg
STARTED	267	276	277	277
COMPLETED	255	252	273	266
NOT COMPLETED	12	24	4	11
Adverse Event	6	22	3	4
Lost to Follow-up	0	1	0	0
Lack of Efficacy	0	0	1	2
Non compliant with protocol	1	0	0	3
Consent withdrawn	2	1	0	1
Other	3	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
Amlodipine 5mg	No text entered.
Amlodipine 10mg	No text entered.
Telmisartan 40mg and Amlodipine 5mg	No text entered.
Telmisartan 80mg and Amlodipine 5mg	No text entered.

Baseline Measures

	Amlodipine 5mg	Amlodipine 10mg	Telmisartan 40mg and Amlodipine 5mg	Telmisartan 80mg and Amlodipine 5mg	Total
Number of Participants [units: participants]	267	276	277	277	1097
Age [units: Years] Mean ± Standard Deviation	54 ± 10.6	54.3 ± 10.6	53.9 ± 11	54.5 ± 10.2	54.2 ± 10.6
Gender [units: participants]
Female	104	100	117	94	415
Male	163	176	160	183	682

Outcome Measures

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1. Primary:

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

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2. Primary:

Number of Patients With Oedema [ Time Frame: During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment) ]

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3. Secondary:

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

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4. Secondary:

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

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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:	NCT00558428 History of Changes
Other Study ID Numbers:	1235.5, EUDRACT2007-002409-36
Study First Received:	October 29, 2007
Results First Received:	November 13, 2009
Last Updated:	July 4, 2011
Health Authority:	Belgium: Federal Agency for Medicines and Health Products; Canada: Health Canada (TPD); Denmark: Lægemiddelstyrelsen Kliniskeforsøg, Inspektionen Axel Heides Gade 1 DK-2300 Copenhagen S; Finland: HUS Ethics Committee; France: AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTE; Korea, Republic of: Korea Food and Drug Administration (KFDA); Netherlands: Central Committee on Research Involving Human Subjects (CCMO); Norway: Norwegian Medicines Agency (Statens Legemiddelverk); Philippines: Department of Health, Republic of the Philippines; South Africa: Medicines Control Council; Sweden: Regional Ethics Committee of Stockholm, PO Box 289, SE-17177 Stockholm, Sweden. Medical Products Agency; Taiwan: Department of Health, Executive Yuan, Taiwan; United States: Food and Drug Administration