Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients (in-MAU-tion)

• Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.
  
  
• Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.
  
  
• Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.
  
  

• Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 3 Months [ Time Frame: Baseline, 3 Months ] [ Designated as safety issue: No ]
  Diabetics were considered to be "BP-controlled" if BP <130/80 mm Hg. Diabetics were considered to be "BP-uncontrolled" if BP >/=130/80 mm Hg.
  
  
• Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 6 Months [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
  Diabetics were considered to be "BP-controlled" if BP <130/80 mm Hg. Diabetics were considered to be "BP-uncontrolled" if BP >/=130/80 mm Hg.
  
  
• Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 12 Months [ Time Frame: Baseline,12 Months ] [ Designated as safety issue: No ]
  Diabetics were considered to be "BP-controlled" if BP <130/80 mm Hg. Diabetics were considered to be "BP-uncontrolled" if BP >/=130/80 mm Hg.
  
  
• Change From Baseline in Microalbuminuria (MAU) at 3 Months [ Time Frame: Baseline, 3 Months ] [ Designated as safety issue: No ]
  
• Change From Baseline in Microalbuminuria (MAU) at 6 Months [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
  
• Change From Baseline in Microalbuminuria (MAU) at 12 Months [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
  
• Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 3 Months of Therapy [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as "controlled."
  
  
• Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 6 Months of Therapy [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as "controlled."
  
  
• Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 12 Months of Therapy [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as "controlled."
  
  
• Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy [ Time Frame: Day 0 (Baseline), 12 months ] [ Designated as safety issue: No ]
  Satisfaction with therapy at baseline (BL) and 12 months, using a 5-point Likert scale where participants responded to the question "Are you satisfied with your current hypertension therapy?". The range of responses varied from "1 = not at all satisfied" to "5 = extremely satisfied." Responses "2" through "4" were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively.
  
  
• Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy [ Time Frame: Day 0 (Baseline), 12 months ] [ Designated as safety issue: No ]
  Satisfaction with therapy at baseline (BL) versus 12 months, using a 5-point Likert scale where participants responded to the question "Are you satisfied with your current hypertension therapy?". The range of responses varied from "1 = not at all satisfied" to "5 = extremely satisfied." Responses "2" through "4" were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively.
  
  

• Percentage of Participants Achieving 2008 CHEP Targets After 3 Months of Therapy [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  Blood Pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."
  
  
• Percentage of Participants Achieving 2008 CHEP Targets After 6 Months of Therapy [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."
  
  
• Percentage of Participants Achieving 2008 CHEP Targets After 12 Months of Therapy [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."
  
  
• Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 3 Months of Therapy [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."
  
  
• Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 6 Months of Therapy [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."
  
  
• Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 12 Months of Therapy [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."
  
  
• Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 3 Months [ Time Frame: Day 0 (Baseline), 3 Months ] [ Designated as safety issue: No ]
  
• Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 6 Months [ Time Frame: Day 0 (Baseline), 6 Months ] [ Designated as safety issue: No ]
  
• Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 12 Months [ Time Frame: Day 0 (Baseline), 12 Months ] [ Designated as safety issue: No ]
  
• Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts [ Time Frame: Day 0 (Baseline) ] [ Designated as safety issue: No ]
  
• Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3 [ Time Frame: Day 0 (Baseline), Month 3 ] [ Designated as safety issue: No ]
  
• Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6 [ Time Frame: Day 0 (Baseline), Month 6 ] [ Designated as safety issue: No ]
  
• Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12 [ Time Frame: Day 0 (Baseline), Month 12 ] [ Designated as safety issue: No ]
  
• Number of Participants Compliant With Therapy After 3 Months [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  Compliance after 3 months of treatment was derived using responses to the Visit 2 question "How many trandolapril (Mavik®) doses have been missed since the subject's last visit?" If the response was "zero", the participant was classified as "compliant." If the response was any value greater than zero, regardless of the number of missed doses, the participant was classified as "non-compliant."
  
  
• Number of Participants Compliant With Therapy After 6 Months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  Compliance after 6 months of treatment was derived using responses to the question "How many trandolapril (Mavik®) doses have been missed since the subject's last visit?" at both Visit 2 and Visit 3, as follows: If the response was "zero" at both the Visit 2 and Visit 3 assessments, participant was classified as "compliant" after 6 months of treatment; If the response was any value greater than zero at either of the Visit 2 or Visit 3 assessments, regardless of the number of missed doses, participant was classified as "non-compliant" after 6 months of treatment
  
  
• Number of Participants Compliant With Therapy After 12 Months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  Compliance after 12 months of treatment was derived using responses to the question "How many trandolapril doses have been missed since the subject's last visit?" at Visit 2, Visit 3 and Visit 4, as follows: if the response was "zero" at all of the Visits 2 through 4 assessments, the participant was classified as "compliant" after 12 months of treatment; if the response was any value greater than zero at any of the Visits 2 through 4 assessments, regardless of the number of missed doses, the participant was classified as "non-compliant" after 12 months of treatment.
  
  
• Number of Participants With Dose Changes at 3 Months [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  
• Number of Participants With Dose Changes at 6 Months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  
• Number of Participants With Dose Changes at 12 Months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  
• Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were "controlled" versus "uncontrolled" was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these "controlled" and "uncontrolled" participants who underwent or did not undergo a dose increase is presented.
  
  
• Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were "controlled" versus "uncontrolled" was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these "controlled" and "uncontrolled" participants who underwent or did not undergo a dose increase is presented.
  
  
• Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were "controlled" versus "uncontrolled" was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these "controlled" and "uncontrolled" participants who underwent or did not undergo a dose increase is presented.
  
  
• Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  Presented by type of medication added.
  
  
• Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  Presented by type of medication added.
  
  
• Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  Presented by type of medication added.
  
  
• Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  Presented by type of medication discontinued.
  
  
• Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  Presented by type of medication discontinued.
  
  
• Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  Presented by type of medication discontinued.
  
  
• Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 3 Months [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  Participants achieving the target of blood pressure <140/90 mm Hg were considered "controlled."
  
  
• Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 6 Months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  Participants achieving the target of blood pressure <140/90 mm Hg were considered "controlled."
  
  
• Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 12 Months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  Participants achieving the target of blood pressure <140/90 mm Hg were considered "controlled."
  
  

There are no interventional implications in this study. The study runs under consideration of Canadian Hypertension Education Program guidelines and as per standard practice of care. Data collection is recorded on the appropriate case report forms. The data collected consist of: patient demographics (gender, race, age, weight), blood pressure readings, heart rate, coexisting comorbidities, concomitant chronic medications (generic name and dosage), indication and dose for trandolapril (Mavik®) and patient compliance. Laboratory values (microalbuminuria, estimated glomerular filtration rate) are only collected if the data are available for each patient. For baseline values (study Day 0), any laboratory value recorded within the past year prior to the baseline visit (Visit 1) is recorded, if the value is available. As per Canadian Hypertension Education Program recommendations and as a support and educational measure, patients are provided with (1) educational tools (nutrition guidebooks) and (2) home blood pressure monitoring devices. As per research and development guidelines, blood pressure devices were retrieved at the end of the study. Approximately 8,000 hypertensive participants were enrolled in the study at up to 700 sites across Canada. Sample size estimations were based on the assumption that 67.2% of non-diabetic hypertensive participants (assumed to make up to 69% of the eligible participant population) would reach a blood pressure target of <140/90mm Hg, while 22% of diabetes participants (31% of the eligible population) would meet a blood pressure target of <130/80 mm Hg with trandolapril (Mavik®) therapy.