26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension

This study has been completed.

Study NCT00624052 Information provided by Boehringer Ingelheim Pharmaceuticals

First Received on February 5, 2008. Last Updated on September 1, 2010 History of Changes

Results First Received: December 28, 2009

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: fixed-dose combination of telmisartan 40mg+amlodipine 10mg Drug: fixed-dose combination of telmisartan 80mg+amlodipine10mg

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 40mg and Amlodipine 10mg	Patients who were randomised to telmisartan 40mg and amlodipine 10mg and were on this dose at their last study visit
Randomised Telmisartan 80mg and Amlodipine 10mg	Patients who were randomised to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit
Titrated Telmisartan 80mg and Amlodipine 10mg	Patients who were randomised to telmisartan 40mg and amlodipine 10mg but were titrated to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on	Patients who were on either telmisartan 40 mg or 80mg and amlodipine 10mg plus another antihypertensive medication at their last study visit

Participant Flow: Overall Study

	Telmisartan 40mg and Amlodipine 10mg	Randomised Telmisartan 80mg and Amlodipine 10mg	Titrated Telmisartan 80mg and Amlodipine 10mg	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
STARTED	219	436	91	92
COMPLETED	204	422	88	88
NOT COMPLETED	15	14	3	4
Adverse Event	7	6	0	3
Lack of Efficacy	1	1	0	0
Lost to Follow-up	2	3	1	0
Non compliant with the protocol	2	1	1	1
Consent withdrawn	3	1	1	0
Changed job/ran out if meds	0	2	0	0

Baseline Characteristics

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Reporting Groups

	Description
Telmisartan 40mg and Amlodipine 10mg	No text entered.
Randomised Telmisartan 80mg and Amlodipine 10mg	No text entered.
Titrated Telmisartan 80mg and Amlodipine 10mg	No text entered.
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on	No text entered.

Baseline Measures

	Telmisartan 40mg and Amlodipine 10mg	Randomised Telmisartan 80mg and Amlodipine 10mg	Titrated Telmisartan 80mg and Amlodipine 10mg	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on	Total
Number of Participants [units: participants]	219	436	91	92	838
Age [units: Years] Mean ± Standard Deviation	56.2 ± 9.9	57.3 ± 9.4	55.2 ± 9.7	53.3 ± 10.3	56.4 ± 9.7
Gender [units: Participants]
Female	93	206	31	37	367
Male	126	230	60	55	471

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 to End of Study in Trough Seated Diastolic Blood Pressure [ Time Frame: Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment ]

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4. Secondary:

Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052 [ Time Frame: Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment) ]

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5. Secondary:

Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure [ Time Frame: Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment ]

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6. Secondary:

Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052 [ Time Frame: Last available trough in NCT00624052 to 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 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: up to 34 weeks ]

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11. Secondary:

Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control [ Time Frame: up to 34 weeks ]

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12. Secondary:

Additional Reduction in DBP by Use of Additional Antihypertensive Therapy [ Time Frame: up to 34 weeks ]

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13. Secondary:

Additional Reduction in SBP by Use of Additional Antihypertensive Therapy [ Time Frame: up to 34 weeks ]

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14. Secondary:

Trough DBP Control Pre- and Post- Uptitration [ Time Frame: up to 34 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:	NCT00624052 History of Changes
Other Study ID Numbers:	1235.8
Study First Received:	February 5, 2008
Results First Received:	December 28, 2009
Last Updated:	September 1, 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 prov. 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 (AEMPS); Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)