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Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension
This study has been completed.

First Received on January 24, 2006.   Last Updated on April 28, 2010   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00281580
  Purpose

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


Condition Intervention Phase
Hypertension
 Drug: Telmisartan
Drug: Amlodipine
 Phase III

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Amlodipine Amlodipine besylate Telmisartan
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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

  • Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
    Telmisartan treatment effect on outcome measure

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

  • 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) ]
    Amlodipine treatment effect on outcome measure

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

  • Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, All Treatment Groups) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
    Individual treatment group effects (all patients)

  • 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) ]
    Individual treatment group effects (excluding placebo patients)

  • Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
    Observed results for moderate-severe (mod-sev) patients

  • Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
    Telm Effect - mod-sev patients

  • Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ]
    Observed results for mod-sev patients

  • Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ]
    Amlodipine Effect (Amlo Effect) - mod-sev patients

  • Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ]
    ANCOVA results for mod-sev patients

  • Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ]
    ANCOVA results for mod-sev patients (excluding placebo)


Secondary Outcome Measures:
  • Change From Baseline at 8 Weeks in Seated Trough Cuff Mean SBP (Adjusted Treatment Effects, All Treatment Groups) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
    Individual treatment group effects (all patients)

  • Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP (Adjusted Treatment Effects, All Treatment Groups) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
    Individual treatment group effects (all patients)

  • Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP (Adjusted Treatment Effects, All Treatment Groups) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
    Individual treatment group effects (all patients)

  • Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP (Observed Treatment Effects) [ Time Frame: Baseline to nominal week over the trial ]
    Observed results for all patients - key combination therapies

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

  • DBP Response [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
    Percentage of responders (DBP<90 mmHg or >=10 mmHg reduction) for all patients - key combination therapies

  • SBP Response [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
    Percentage of responders (SBP<140 mmHg or >=10 mmHg reduction) for all patients - key combination therapies

  • 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

  • BP Normality [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
    Category based on both SBP and DBP (mmHg) for all patients - key combination therapies

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

  • Change From Baseline in ABPM 24-hour Mean DBP (Observed Treatment Effects) [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
    Observed results for all patients - key combination therapies

  • Change From Baseline in ABPM 24-hour Mean SBP (Observed Treatment Effects) [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
    Observed results for all patients - key combination therapies

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

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

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

  • Change From Baseline in Seated Trough Cuff Mean SBP [ Time Frame: Up to 8 weeks (LOCF) ]
    ANCOVA results for mod-sev patients

  • Change From Baseline in Standing Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ]
    ANCOVA results for mod-sev patients

  • Change From Baseline in Standing Trough Cuff Mean SBP [ Time Frame: Up to 8 weeks (LOCF) ]
    ANCOVA results for mod-sev patients

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

  • DBP Control [ Time Frame: Up to 8 weeks (LOCF) ]
    Percentage of responders (DBP<90 mmHg) for mod-sev patients - key combination therapies

  • DBP Response [ Time Frame: Up to 8 weeks (LOCF) ]
    Percentage of responders (DBP<90 mmHg or >=10 mmHg reduction) for mod-sev patients - key combination therapies

  • SBP Response [ Time Frame: Up to 8 weeks (LOCF) ]
    Percentage of responders (SBP<140 mmHg or >=10 mmHg reduction) for mod-sev patients - key combination therapies

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

  • BP Normality [ Time Frame: Up to 8 weeks (LOCF) ]
    Category based on both SBP and DBP (mmHg) for mod-sev patients - key combination therapies

  • 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

  • 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

  • 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

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

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

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


Enrollment: 1461
Study Start Date: April 2006
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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 angioplasy, unstable angina or coronary artery bypass graft within the past three months;
  • unstable or uncontrolled diabetes for the past three months defined as a glocosylated 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 greaten than or equal to 110 mmHg
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281580

  Show 136 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00281580     History of Changes
Other Study ID Numbers: 1235.1
Study First Received: January 24, 2006
Results First Received: November 18, 2009
Last Updated: April 28, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012



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