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Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00281580
Recruitment Status : Completed
First Posted : January 25, 2006
Results First Posted : April 28, 2010
Last Update Posted : March 27, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pre ssure.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Amlodipine 5 mg Drug: Placebo Drug: Telmisartan 20 mg Drug: Telmisartan 40 mg Drug: Amlodipine 10 mg Drug: Telmisartan 80 mg Drug: Amlodipine 2.5 mg Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1461 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, 4x4 Factorial Design Trial to Evaluate Telmisartan 20, 40 and 80 mg Tablets in Combination With Amlodipine 2.5, 5 and 10 mg Capsules After Eight Weeks of Treatment in Patients With Stage I or II Hypertension, With an ABPM Sub-study
Study Start Date : April 2006
Actual Primary Completion Date : March 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo once daily for eight weeks
 Drug: Placebo
Placebo to Telmisartan and Amlodipine once daily for eight weeks
Experimental: Telmisartan 20 mg
Telmisartan 20 mg once daily for eight weeks
 Drug: Telmisartan 20 mg
Telmisartan 20 mg once daily for eight weeks
Experimental: Telmisartan 40 mg
Telmisartan 40 mg once daily for eight weeks
 Drug: Telmisartan 40 mg
Telmisartan 40 mg once daily for eight weeks
Experimental: Telmisartan 80 mg
Telmisartan 80 mg once daily for eight weeks
 Drug: Telmisartan 80 mg
Telmisartan 80 mg once daily for eight weeks
Experimental: Amlodipine 2.5 mg
Amlodipine 2.5 mg once daily for eight weeks
 Drug: Amlodipine 2.5 mg
Amlodipine 2.5 mg once daily for eight weeks
Experimental: Amlodipine 5 mg
Amlodipine 5 mg once daily for eight weeks
 Drug: Amlodipine 5 mg
amlodipine 5g once daily for eight weeks
Active Comparator: Amlodipine 10 mg
Amlodipine 5 mg for two weeks and forced titrated to amlodipine 10 mg for six weeks once daily
 Drug: Amlodipine 5 mg
amlodipine 5g once daily for two weeks

Drug: Amlodipine 10 mg
Amlodipine 10 mg once daily for six weeks
Experimental: Telmisartan 20 / Amlodipine 2.5
Telmisartan 20/ Amlodipine 2.5 mg once daily for eight weeks
 Drug: Telmisartan 20 mg
Telmisartan 20 mg once daily for eight weeks

Drug: Amlodipine 2.5 mg
Amlodipine 2.5 mg once daily for eight weeks
Experimental: Telmisartan 20 / Amlodipine 5
Telmisartan 20 / Amlodipine 5 mg once daily for eight weeks
 Drug: Telmisartan 20 mg
Telmisartan 20 mg once daily for eight weeks

Drug: Amlodipine 5 mg
amlodipine 5mg once daily for eight weeks
Experimental: Telmisartan 20 / Amlodipine 10
Telmisartan 20 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
 Drug: Amlodipine 10 mg
Amlodipine 10 mg once daily for six weeks

Drug: Telmisartan 20 mg
Telmisartan 20 mg once daily for eight weeks

Drug: Amlodipine 5 mg
Amlodipine 5 mg once daily for two weeks
Experimental: Telmisartan 40 / Amlodipine 2.5
Telmisartan 40 / Amlodipine 2.5 for eight weeks
 Drug: Amlodipine 2.5 mg
Amlodipine 2.5 mg once daily for eight weeks

Drug: Telmisartan 40 mg
Telmisartan 40 mg once daily for eight weeks
Experimental: Telmisartan 40 / Amlodipine 5
Telmisartan 40 / Amlodipine 5 for eight weeks
 Drug: Amlodipine 5 mg
Amlodipine 5 mg once daily for eight weeks

Drug: Telmisartan 40 mg
Telmisartan 40 mg once daily for eight weeks
Experimental: Telmisartan 40 / Amlodipine 10
Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
 Drug: Telmisartan 40 mg
Telmisartan 40 mg once daily for eight weeks

Drug: Amlodipine 10 mg
Amlodipine 10 mg once daily for six weeks

Drug: Amlodipine 5 mg
Amlodipine 5 mg once daily for two weeks
Experimental: Telmisartan 80 / Amlodipine 2.5
Telmisartan 80 / Amlodipine 2.5 for eight weeks
 Drug: Amlodipine 2.5 mg
Amlodipine 2.5 mg once daily for eight weeks

Drug: Telmisartan 80 mg
Telmisartan 80 mg once daily for eight weeks
Experimental: Telmisartan 80 / Amlodipine 5
Telmisartan 80 / Amlodipine 5 mg for eight weeks
 Drug: Telmisartan 80 mg
Telmisartan 80 mg once daily for eight weeks

Drug: Amlodipine 5 mg
Amlodipine 5 mg once daily for eight weeks
Experimental: Telmisartan 80 / Amlodipine 10
Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
 Drug: Amlodipine 5 mg
Amlodipine 5 mg once daily for two weeks

Drug: Telmisartan 80 mg
Telmisartan 80 mg once daily for eight weeks

Drug: Amlodipine 10 mg
Amlodipine 10 mg once daily for six weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF)) ]
    Observed results

  2. Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

  3. Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
    Observed results

  4. Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

  5. Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) [ Time Frame: End-of-study visit (LOCF) ]
    Observed results

  6. Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

  7. Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

  8. Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
    Observed results

  9. Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

  10. Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) [ Time Frame: Up to 8 weeks (LOCF) ]
    Observed results

  11. Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) [ Time Frame: Up to 8 weeks (LOCF) ]
    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

  12. Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) [ Time Frame: Up to 8 weeks (LOCF) ]
    Observed results

  13. Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) [ Time Frame: Up to 8 weeks (LOCF) ]
    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

  14. Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) [ Time Frame: Up to 8 weeks (LOCF) ]
    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.


Secondary Outcome Measures :
  1. Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.

  2. Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

  3. Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.

  4. DBP Control [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
    DBP control is defined as DBP < 90 mmHg - key combination therapies

  5. DBP Response [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
    DBP response is defined as DBP < 90 mmHg or a reduction of DBP of >= 10 mmHg - key combination therapies

  6. SBP Response [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
    SBP Response is defined as SBP < 140 mmHg or a reduction of SBP of >= 10 mmHg - key combination therapies

  7. BP Normality [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]

    No: Mean seated SBP >=140 and/or mean seated DBP >=90 mmHg at trough High normal: mean seated SBP >=130 and <140 mmHg and mean seated DBP >=85 and <90 mmHg at trough Normal: mean seated SBP >=120 and <130 mmHg and mean seated DBP >=80 and <85 mmHg at trough Optimal: mean seated SBP < 120 mmHg and mean seated DBP <80 mmHg at trough

    - key combination therapies


  8. Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
    Observed results - key combination therapies

  9. Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
    Observed results - key combination therapies

  10. Change From Baseline in ABPM 24-hour Mean DBP [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
    Observed results - key combination therapies

  11. Change From Baseline in ABPM 24-hour Mean SBP [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
    Observed results - key combination therapies

  12. Orthostatic Change in Trough Cuff Mean DBP [ Time Frame: Week 8 ]
    Calculated as seated minus standing for all patients - key combination therapies

  13. Orthostatic Change in Trough Cuff Mean SBP [ Time Frame: Week 8 ]
    Calculated as seated minus standing for all patients - key combination therapies

  14. Change From Baseline in Seated Trough Pulse Rate [ Time Frame: End-of-study visit (LOCF) ]
    Observed results for all patients - key combination therapies

  15. Change From Baseline in Seated Trough Cuff Mean SBP [ Time Frame: Up to 8 weeks (LOCF) ]
    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.

  16. Change From Baseline in Standing Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ]
    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

  17. Change From Baseline in Standing Trough Cuff Mean SBP [ Time Frame: Up to 8 weeks (LOCF) ]
    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.

  18. DBP Control [ Time Frame: Up to 8 weeks (LOCF) ]
    DBP control is defined as DBP < 90 mmHg - key combination therapies

  19. DBP Response [ Time Frame: Up to 8 weeks (LOCF) ]
    DBP response is defined as DBP < 90 mmHg or a reduction of DBP of >= 10 mmHg - key combination therapies

  20. SBP Response [ Time Frame: Up to 8 weeks (LOCF) ]
    SBP Response is defined as SBP < 140 mmHg or a reduction of SBP of >= 10 mmHg - key combination therapies

  21. BP Normality [ Time Frame: Up to 8 weeks (LOCF) ]

    No: Mean seated SBP >=140 and/or mean seated DBP >=90 mmHg at trough High normal: mean seated SBP >=130 and <140 mmHg and mean seated DBP >=85 and <90 mmHg at trough Normal: mean seated SBP >=120 and <130 mmHg and mean seated DBP >=80 and <85 mmHg at trough Optimal: mean seated SBP < 120 mmHg and mean seated DBP <80 mmHg at trough

    - key combination therapies


  22. Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP [ Time Frame: Up to 8 weeks (LOCF) ]
    Observed results for mod-sev patients - key combination therapies

  23. Change From Baseline in ABPM 24-hour Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ]
    Observed results for mod-sev patients - key combination therapies

  24. Change From Baseline in ABPM 24-hour Mean SBP [ Time Frame: Up to 8 weeks (LOCF) ]
    Observed results for mod-sev patients - key combination therapies

  25. Orthostatic Change in Trough Cuff Mean DBP [ Time Frame: Week 8 ]
    Calculated as seated minus standing for mod-sev patients - key combination therapies

  26. Orthostatic Change in Trough Cuff Mean SBP [ Time Frame: Week 8 ]
    Calculated as seated minus standing for mod-sev patients - key combination therapies

  27. Change From Baseline in Seated Trough Pulse Rate [ Time Frame: Up to 8 weeks (LOCF) ]
    Observed results for mod-sev patients - key combination therapies

  28. Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) [ Time Frame: 8 weeks ]
    Clinical relevant abnormalities for laboratory parameters and Electrocardiogram (ECG). New abnormal findings or worsening of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).


Other Outcome Measures:
  1. Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP [ Time Frame: Baseline to nominal week over the trial ]
    Observed results for key combination therapies

  2. BP Control [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
    Percentage of responders (SBP<140 mmHg and DBP<90 mmHg) for all patients - key combination therapies

  3. Change From Baseline in Seated Trough Cuff DBP [ Time Frame: Nominal week over the trial ]
    Observed results for mod-sev patients - key combination therapies

  4. BP Control [ Time Frame: Up to 8 weeks (LOCF) ]
    Responders SBP<10 mmHg and DBP<90 mmHg) for mod-sev patients - key combination therapies


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Main Inclusion Criteria: Male and female patients >=18 years of age with Stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure >=95 and <=119 mmHg Main

Exclusion criteria:

Exclusion Criteria:

  1. Patient is pregnant; breast-feeding; unwilling to use birth control during the study; has secondary hypertension; severe renal dysfunction; hepatic insufficiency; stroke within the last six months; myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months; unstable or uncontrolled diabetes for the past three months defined as a glucosylates hemoglobin (HbA1c) greater than ten percent ; history of angioedema or hypersensitivity related to either study drug.
  2. Systolic Blood Pressure (SBP) is greater than or equal to 180 millimeters of mercury (mmHg), Diastolic Blood Pressure (DBP) is greater than or equal to 110 mmHg.
Contacts and Locations
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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): NCT00281580


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00281580    
Other Study ID Numbers: 1235.1
2008-000874-19 ( EudraCT Number: EudraCT )
First Posted: January 25, 2006    Key Record Dates
Results First Posted: April 28, 2010
Last Update Posted: March 27, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Antihypertensive Agents
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists