Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: amlodipine Drug: telmisartan Drug: telmisartan and amlodipine

	T80+A10	Telmisartan 80 mg	Amlodipine 10 mg
STARTED	421	217	220
COMPLETED	401	195	202
NOT COMPLETED	20	22	18
Adverse Event	9	6	7
Protocol Violation	0	1	0
Lost to Follow-up	2	0	1
Withdrawal by Subject	4	8	6
Lack of Efficacy	0	4	3
Not Specified	5	3	1

Baseline Characteristics

Reporting Groups

	Description
T80+A10	Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
Telmisartan 80 mg	Telmisartan 80 mg once daily (T80)
Amlodipine 10 mg	Amlodipine 10 mg once daily (A10)

Baseline Measures

	T80+A10	Telmisartan 80 mg	Amlodipine 10 mg	Total
Number of Participants [units: participants]	421	217	220	858
Age [units: years] Mean ± Standard Deviation	58.0 ± 10.4	58.1 ± 10.2	58.6 ± 10.5	58.2 ± 10.3
Age, Customized [units: Participants]
< 65 years	309	158	156	623
>= 65 years	112	59	64	235
Gender [units: participants]
Female	202	109	102	413
Male	219	108	118	445
Race/Ethnicity, Customized [units: participants]
White	362	186	190	738
Black/African American	34	15	15	64
Asian	20	14	14	48
American Indian/Alaska Native	5	1	0	6
Hawaiian/Pacific Islander	0	1	1	2
Body Mass Index (BMI) [units: kilograms/square meter] Mean ± Standard Deviation	30.6 ± 5.9	30.2 ± 5.2	30.7 ± 6.3	30.6 ± 5.8
Body Mass Index Class [units: participants]
BMI < 25	63	31	35	129
25 <= BMI < 30	160	79	82	321
BMI >= 30	198	107	103	408
Race Class [units: participants]
Non-Black	387	202	205	794
Black	34	15	15	64
Type II Diabetes [units: participants]
No	349	183	197	729
Yes	72	34	23	129
Duration of Hypertension [units: years] Mean ± Standard Deviation	10.3 ± 9.6	9.4 ± 9.2	10.3 ± 10.1	10.1 ± 9.6
Duration of Hypertension Class [units: participants]
< 1 year	38	25	20	83
1 - 5 years	124	64	72	260
6 - 10 years	103	61	54	218
> 10 years	156	67	74	297
Number of previous antihypertensive treatments [units: participants]
0	49	37	26	112
1	133	67	78	278
2	136	59	71	266
>= 3	103	54	45	202

Outcome Measures

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1. Primary:

Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 [ Time Frame: baseline and week 8 ]

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2. Secondary:

Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6 [ Time Frame: baseline and week 6 ]

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3. Secondary:

Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4 [ Time Frame: baseline and week 4 ]

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4. Secondary:

Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8 [ Time Frame: baseline and week 8 ]

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5. Secondary:

Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6 [ Time Frame: baseline and week 6 ]

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6. Secondary:

Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4 [ Time Frame: baseline and week 4 ]

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7. Secondary:

Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2 [ Time Frame: baseline and week 2 ]

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8. Secondary:

Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1 [ Time Frame: baseline and week 1 ]

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9. Secondary:

Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2 [ Time Frame: baseline and week 2 ]

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10. Secondary:

Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1 [ Time Frame: baseline and week 1 ]

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11. Secondary:

Patients Achieving Diastolic Blood Pressure Control at Week 1 [ Time Frame: week 1 ]

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12. Secondary:

Patients Achieving Diastolic Blood Pressure Control at Week 2 [ Time Frame: week 2 ]

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13. Secondary:

Patients Achieving Blood Pressure Control at Week 1 [ Time Frame: week 1 ]

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14. Secondary:

Patients Achieving Blood Pressure Control at Week 2 [ Time Frame: week 2 ]

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15. Secondary:

Patients Achieving Diastolic Blood Pressure Response at Week 1 [ Time Frame: baseline, week 1 ]

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16. Secondary:

Patients Achieving Diastolic Blood Pressure Response at Week 2 [ Time Frame: baseline, week 2 ]

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17. Secondary:

Patients Achieving Systolic Blood Pressure Response at Week 1 [ Time Frame: baseline, week 1 ]

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18. Secondary:

Patients Achieving Systolic Blood Pressure Response at Week 2 [ Time Frame: baseline, week 2 ]

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19. Secondary:

Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 [ Time Frame: week 1 ]

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20. Secondary:

Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 [ Time Frame: week 2 ]

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21. Secondary:

Patients Achieving Diastolic Blood Pressure Control at Week 4 [ Time Frame: week 4 ]

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22. Secondary:

Patients Achieving Diastolic Blood Pressure Control at Week 6 [ Time Frame: week 6 ]

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23. Secondary:

Patients Achieving Diastolic Blood Pressure Control at Week 8 [ Time Frame: week 8 ]

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24. Secondary:

Patients Achieving Blood Pressure Control at Week 4 [ Time Frame: week 4 ]

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25. Secondary:

Patients Achieving Blood Pressure Control at Week 6 [ Time Frame: week 6 ]

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26. Secondary:

Patients Achieving Blood Pressure Control at Week 8 [ Time Frame: week 8 ]

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27. Secondary:

Patients Achieving Diastolic Blood Pressure Response at Week 4 [ Time Frame: baseline, week 4 ]

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28. Secondary:

Patients Achieving Diastolic Blood Pressure Response at Week 6 [ Time Frame: baseline, week 6 ]

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29. Secondary:

Patients Achieving Diastolic Blood Pressure Response at Week 8 [ Time Frame: baseline, week 8 ]

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30. Secondary:

Patients Achieving Systolic Blood Pressure Response at Week 4 [ Time Frame: baseline, week 4 ]

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31. Secondary:

Patients Achieving Systolic Blood Pressure Response at Week 6 [ Time Frame: baseline, week 6 ]

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32. Secondary:

Patients Achieving Systolic Blood Pressure Response at Week 8 [ Time Frame: baseline, week 8 ]

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33. Secondary:

Patients Achieving Normal Blood Pressure Response at Week 4 [ Time Frame: week 4 ]

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34. Secondary:

Patients Achieving Normal Blood Pressure Response at Week 6 [ Time Frame: week 6 ]

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35. Secondary:

Patients Achieving Normal Blood Pressure Response at Week 8 [ Time Frame: week 8 ]

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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
No text entered.

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:	NCT00860262 History of Changes
Other Study ID Numbers:	1235.20, 2008-000873-40
Study First Received:	March 11, 2009
Results First Received:	December 10, 2010
Last Updated:	February 14, 2011
Health Authority:	Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia; Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; France: AFFSAPS; Hungary: National Institute of Pharmacy, H-1051 Budapest; Korea, Republic of: Korea Food and Drug Administration (KFDA); Romania: National Medicines Agency, Bucharest; 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) Subdirección General de Medicamentos de uso humano Parque empresarial las Mercedes, edificio 8 C/ Campezo, 1 28022 Madrid / SPAIN; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine); United States: Food and Drug Administration