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Completed

NCT Number: NCT00281580

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

To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pre ssure.

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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

1235.1.001 Boehringer Ingelheim Investigational Site, BsAs, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

  • 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.
  • 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.

Treatment and study plan

Amlodipine 5 mg

Drug

Amlodipine 5 mg once daily for two weeks

Placebo

Drug

Placebo to Telmisartan and Amlodipine once daily for eight weeks

Telmisartan 20 mg

Drug

Telmisartan 20 mg once daily for eight weeks

Telmisartan 40 mg

Drug

Telmisartan 40 mg once daily for eight weeks

Amlodipine 10 mg

Drug

Amlodipine 10 mg once daily for six weeks

Telmisartan 80 mg

Drug

Telmisartan 80 mg once daily for eight weeks

Amlodipine 2.5 mg

Drug

Amlodipine 2.5 mg once daily for eight weeks

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
First posted
Jan 25, 2006
Registry last updated
Mar 27, 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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