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Completed

NCT Number: NCT00860262

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1235.20.001 Boehringer Ingelheim Investigational Site, Burgas, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
  • Age 18 years or older
  • Patients with severe hypertension as defined SBP greater than 180 mmHg and DBP greater than 95 mmHg at randomisation
  • 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

Treatment and study plan

Amlodipine

Drug

amlodipine 5mg for the first 2w then force titration to Amlodipine 10mg for remaining 6 w

Telmisartan

Drug

telmisartan 80mg for the 8w, no titration required

telmisartan and amlodipine

Drug

telmisartan 80 and amlodipine 5mg for the first 2 weeks, then force titrated to telmisartan 80mg and amlodipine 10mg for the remaining 6w

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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).

Important dates

Study start
2009
Primary completion
2009
First posted
Mar 12, 2009
Registry last updated
May 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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