Open Label Study Telmisartan and Amlodipine in Hypertension - Study Results

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: telmisartan/amlodipine 40/5 mg fixed combination Drug: telmisartan/amlodipine 80/5 mg fixed combination

Participant Flow

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 40mg and Amlodipine 5mg	No text entered.
Telmisartan 80mg and Amlodipine 5mg	No text entered.
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	No text entered.
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive	No text entered.

Participant Flow: Overall Study

	Telmisartan 40mg and Amlodipine 5mg	Telmisartan 80mg and Amlodipine 5mg	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
STARTED	564	206	25	181
COMPLETED	529	198	24	179
NOT COMPLETED	35	8	1	2
Adverse Event	14	4	0	0
Lost to Follow-up	6	1	0	0
Non compliant with the protocol	12	2	1	2
Consent withdrawn	3	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
Telmisartan 40mg and Amlodipine 5mg	No text entered.
Telmisartan 80mg and Amlodipine 5mg	No text entered.
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	No text entered.
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive	No text entered.

Baseline Measures

	Telmisartan 40mg and Amlodipine 5mg	Telmisartan 80mg and Amlodipine 5mg	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive	Total
Number of Participants [units: participants]	564	206	25	181	976
Age [units: Years] Mean ± Standard Deviation	54.8 ± 10.9	52.9 ± 10.6	54.4 ± 10.8	52.4 ± 9.6	53.9 ± 10.6
Gender [units: participants]
Female	240	72	8	45	365
Male	324	134	17	136	611

Outcome Measures

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1. Primary:

Trough Seated Diastolic Blood Pressure (DBP) Control [ Time Frame: End of study (34 weeks or last value on treatment) ]

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2. Secondary:

Trough Seated Systolic Blood Pressure (SBP) Control [ Time Frame: End of study (34 weeks or last value on treatment) ]

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3. Secondary:

Change From Baseline in Trough Seated Diastolic Blood Pressure [ Time Frame: End of study (34 weeks or last value on treatment) ]

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4. Secondary:

Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 [ Time Frame: End of study (34 weeks or last value on treatment) ]

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5. Secondary:

Change From Baseline in Trough Seated Systolic Blood Pressure [ Time Frame: End of study (34 weeks or last value on treatment) ]

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6. Secondary:

Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 [ Time Frame: End of study (34 weeks or last value on treatment) ]

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7. Secondary:

Trough Seated DBP Response [ Time Frame: End of study (34 weeks or last value on treatment) ]

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8. Secondary:

Trough Seated SBP Response [ Time Frame: End of study (34 weeks or last value on treatment) ]

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9. Secondary:

Trough Blood Pressure (BP) Normality Classes [ Time Frame: End of study (34 weeks or last value on treatment) ]

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10. Secondary:

Time to First Additional Antihypertensive [ Time Frame: At any point during open-label treatment ]

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11. Secondary:

Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control [ Time Frame: At any point during open-label treatment ]

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12. Secondary:

Additional Reduction in DBP by Use of Additional Antihypertensive Therapy [ Time Frame: At any point during open-label treatment ]

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13. Secondary:

Additional Reduction in SBP by Use of Additional Antihypertensive Therapy [ Time Frame: At any point during open-label treatment ]

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14. Secondary:

Trough DBP Control Pre- and Post- Uptitration [ Time Frame: At any point during open-label 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:	NCT00614380 History of Changes
Other Study ID Numbers:	1235.7, EUDRACT2007-002410-19
Study First Received:	January 28, 2008
Results First Received:	December 14, 2009
Last Updated:	September 1, 2010
Health Authority:	Belgium: Federal Agency for Medicines and Health Products; Canada: Health Canada (TPD); Denmark: Lægemiddelstyrelsen, Kliniske forsøg, Inspektionen Axel Heides Gade 1, DK-2300 Copenhagen S; Finland: Finnish Medicines Agency; 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