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

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”

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

Intervention(s) in this Clinical Trial

• Drug: Telmisartan
• Drug: Amlodipine

Primary 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))
    
• 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)
    
• 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)
    
• 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)
    
• Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)
  • Time Frame: End-of-study visit (LOCF)
    
• 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)
    
• 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)
    
• Change From Baseline in Seated Trough Cuff Mean DBP
  • Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
    
• Change From Baseline in Seated Trough Cuff Mean DBP
  • Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
    
• Change From Baseline in Seated Trough Cuff Mean DBP
  • Time Frame: Up to 8 weeks (LOCF)
    
• Change From Baseline in Seated Trough Cuff Mean DBP
  • Time Frame: Up to 8 weeks (LOCF)
    
• Change From Baseline in Seated Trough Cuff Mean DBP
  • Time Frame: Up to 8 weeks (LOCF)
    
• Change From Baseline in Seated Trough Cuff Mean DBP
  • Time Frame: Up to 8 weeks (LOCF)
    

Secondary 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)
    
• 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)
    
• 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)
    
• 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
    
• DBP Control
  • Time Frame: End-of-study (up to 8 weeks) visit (LOCF)
    
• DBP Response
  • Time Frame: End-of-study (up to 8 weeks) visit (LOCF)
    
• SBP Response
  • Time Frame: End-of-study (up to 8 weeks) visit (LOCF)
    
• BP Control
  • Time Frame: End-of-study (up to 8 weeks) visit (LOCF)
    
• BP Normality
  • Time Frame: End-of-study (up to 8 weeks) visit (LOCF)
    
• 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)
    
• Change From Baseline in ABPM 24-hour Mean DBP (Observed Treatment Effects)
  • Time Frame: End-of-study (up to 8 weeks) visit (LOCF)
    
• Change From Baseline in ABPM 24-hour Mean SBP (Observed Treatment Effects)
  • Time Frame: End-of-study (up to 8 weeks) visit (LOCF)
    
• Orthostatic Change in Trough Cuff Mean DBP
  • Time Frame: Week 8
    
• Orthostatic Change in Trough Cuff Mean SBP
  • Time Frame: Week 8
    
• Change From Baseline in Seated Trough Pulse Rate
  • Time Frame: End-of-study visit (LOCF)
    
• Change From Baseline in Seated Trough Cuff Mean SBP
  • Time Frame: Up to 8 weeks (LOCF)
    
• Change From Baseline in Standing Trough Cuff Mean DBP
  • Time Frame: Up to 8 weeks (LOCF)
    
• Change From Baseline in Standing Trough Cuff Mean SBP
  • Time Frame: Up to 8 weeks (LOCF)
    
• Change From Baseline in Seated Trough Cuff DBP
  • Time Frame: Nominal week over the trial
    
• DBP Control
  • Time Frame: Up to 8 weeks (LOCF)
    
• DBP Response
  • Time Frame: Up to 8 weeks (LOCF)
    
• SBP Response
  • Time Frame: Up to 8 weeks (LOCF)
    
• BP Control
  • Time Frame: Up to 8 weeks (LOCF)
    
• BP Normality
  • Time Frame: Up to 8 weeks (LOCF)
    
• Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
  • Time Frame: Up to 8 weeks (LOCF)
    
• Change From Baseline in ABPM 24-hour Mean DBP
  • Time Frame: Up to 8 weeks (LOCF)
    
• Change From Baseline in ABPM 24-hour Mean SBP
  • Time Frame: Up to 8 weeks (LOCF)
    
• Orthostatic Change in Trough Cuff Mean DBP
  • Time Frame: Week 8
    
• Orthostatic Change in Trough Cuff Mean SBP
  • Time Frame: Week 8
    
• Change From Baseline in Seated Trough Pulse Rate
  • Time Frame: Up to 8 weeks (LOCF)
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Boehringer Ingelheim Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00281580

Study ID Number: 1235.1

ClinicalTrials.gov Identifier: NCT00281580

Health Authority: United States: Food and Drug Administration