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

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ClinicalTrials.gov Identifier: NCT00860262
Recruitment Status : Completed
First Posted : March 12, 2009
Results First Posted : January 4, 2011
Last Update Posted : May 20, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Brief Summary:
The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure [SBP] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.

Condition or disease Intervention/treatment Phase
Hypertension Drug: amlodipine Drug: telmisartan Drug: telmisartan and amlodipine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 858 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 mg & Amlodipine 10mg Versus Telmisartan 80 mg Monotherapy or Amlodipine 10 mg Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3).
Study Start Date : March 2009
Actual Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: telmisartan and amlodipine
telmisartan and amlodipine used in combination vs amlodipine or telmisartan
Drug: telmisartan and amlodipine
telmisartan 80 and amlodipine 5mg for the first 2 weeks, then force titrated to telmisartan 80mg and amlodipine 10mg for the remaining 6w
Active Comparator: amlodipine
telmisartan and amlodipine used in combination vs amlodipine or telmisartan
Drug: amlodipine
amlodipine 5mg for the first 2w then force titration to Amlodipine 10mg for remaining 6 w
Active Comparator: telmisartan
telmisartan and amlodipine used in combination vs amlodipine or telmisartan
Drug: telmisartan
telmisartan 80mg for the 8w, no titration required



Primary Outcome Measures :
  1. Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 [ Time Frame: baseline and week 8 ]
    Overall mean reduction from a common mean baseline in SBP


Secondary Outcome Measures :
  1. Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6 [ Time Frame: baseline and week 6 ]
    Overall mean reduction from a common mean baseline in SBP

  2. Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4 [ Time Frame: baseline and week 4 ]
    Overall mean reduction from a common mean baseline in SBP

  3. Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2 [ Time Frame: baseline and week 2 ]
    Overall mean reduction from a common mean baseline in SBP

  4. Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1 [ Time Frame: baseline and week 1 ]
    Overall mean reduction from a common mean baseline in SBP

  5. Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8 [ Time Frame: baseline and week 8 ]
    Overall mean reduction from a common mean baseline in DBP

  6. Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6 [ Time Frame: baseline and week 6 ]
    Overall mean reduction from a common mean baseline in DBP

  7. Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4 [ Time Frame: baseline and week 4 ]
    Overall mean reduction from a common mean baseline in DBP

  8. Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2 [ Time Frame: baseline and week 2 ]
    Overall mean reduction from a common mean baseline in DBP

  9. Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1 [ Time Frame: baseline and week 1 ]
    Overall mean reduction from a common mean baseline in DBP

  10. Patients Achieving Diastolic Blood Pressure Control at Week 1 [ Time Frame: week 1 ]
    Diastolic Blood Pressure Control is defined as achieving DBP < 90mmHg

  11. Patients Achieving Diastolic Blood Pressure Control at Week 2 [ Time Frame: week 2 ]
    DBP < 90 mmHg

  12. Patients Achieving Blood Pressure Control at Week 1 [ Time Frame: week 1 ]
    Blood Pressure Control is defined as achieving SBP< 140 mmHg and DBP < 90mmHg

  13. Patients Achieving Blood Pressure Control at Week 2 [ Time Frame: week 2 ]
    SBP < 140 mmHg and DBP < 90 mmHg

  14. Patients Achieving Diastolic Blood Pressure Response at Week 1 [ Time Frame: baseline, week 1 ]
    Diastolic Blood Pressure Response is defined as achieving DBP < 90 mmHg or a reduction of >= 10 mmHg

  15. Patients Achieving Diastolic Blood Pressure Response at Week 2 [ Time Frame: baseline, week 2 ]
    DBP < 90 mmHg or reduction of >= 10 mmHg

  16. Patients Achieving Systolic Blood Pressure Response at Week 1 [ Time Frame: baseline, week 1 ]
    Systolic Blood Pressure Response Control is defined as achieving SBP < 140 mmHg or a reduction of >= 15 mmHg

  17. Patients Achieving Systolic Blood Pressure Response at Week 2 [ Time Frame: baseline, week 2 ]
    SBP < 140 mmHg or reduction of >= 15 mmHg

  18. Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 [ Time Frame: week 1 ]
    Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90

  19. Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 [ Time Frame: week 2 ]
    Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90

  20. Patients Achieving Diastolic Blood Pressure Control at Week 4 [ Time Frame: week 4 ]
    DBP < 90 mmHg

  21. Patients Achieving Diastolic Blood Pressure Control at Week 6 [ Time Frame: week 6 ]
    DBP < 90 mmHg

  22. Patients Achieving Diastolic Blood Pressure Control at Week 8 [ Time Frame: week 8 ]
    DBP < 90 mmHg

  23. Patients Achieving Blood Pressure Control at Week 4 [ Time Frame: week 4 ]
    SBP < 140 mmHg and DBP < 90 mmHg

  24. Patients Achieving Blood Pressure Control at Week 6 [ Time Frame: week 6 ]
    SBP < 140 mmHg and DBP < 90 mmHg

  25. Patients Achieving Blood Pressure Control at Week 8 [ Time Frame: week 8 ]
    SBP < 140 mmHg and DBP < 90 mmHg

  26. Patients Achieving Diastolic Blood Pressure Response at Week 4 [ Time Frame: baseline, week 4 ]
    DBP < 90 mmHg or reduction of >= 10 mmHg

  27. Patients Achieving Diastolic Blood Pressure Response at Week 6 [ Time Frame: baseline, week 6 ]
    DBP < 90 mmHg or reduction of >= 10 mmHg

  28. Patients Achieving Diastolic Blood Pressure Response at Week 8 [ Time Frame: baseline, week 8 ]
    DBP < 90 mmHg or reduction of >= 10 mmHg

  29. Patients Achieving Systolic Blood Pressure Response at Week 4 [ Time Frame: baseline, week 4 ]
    SBP < 140 mmHg or reduction of >= 15 mmHg

  30. Patients Achieving Systolic Blood Pressure Response at Week 6 [ Time Frame: baseline, week 6 ]
    SBP < 140 mmHg or reduction of >= 15 mmHg

  31. Patients Achieving Systolic Blood Pressure Response at Week 8 [ Time Frame: baseline, week 8 ]
    SBP < 140 mmHg or reduction of >= 15 mmHg

  32. Patients Achieving Normal Blood Pressure Response at Week 4 [ Time Frame: week 4 ]
    Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90

  33. Patients Achieving Normal Blood Pressure Response at Week 6 [ Time Frame: week 6 ]
    Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90

  34. Patients Achieving Normal Blood Pressure Response at Week 8 [ Time Frame: week 8 ]
    Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
  2. Age 18 years or older
  3. Patients with severe hypertension as defined SBP greater than 180 mmHg and DBP greater than 95 mmHg at randomisation
  4. Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigators discretion)

Exclusion criteria Mean in-clinic seated cuff SBP >/= 200 mmHg and/or Diastolic Blood Pressure [DBP] >/= 95 mmHg


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860262


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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00860262     History of Changes
Other Study ID Numbers: 1235.20
2008-000873-40 ( EudraCT Number: EudraCT )
First Posted: March 12, 2009    Key Record Dates
Results First Posted: January 4, 2011
Last Update Posted: May 20, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists