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

This study has been completed.
Sponsor:
Collaborator:
McKesson Canada
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01078584
First received: March 1, 2010
Last updated: October 19, 2012
Last verified: October 2012
  Purpose

The in-MAU-tion study is conducted to determine the percentage of hypertensive participants with or without diabetes reaching CHEP (Canadian Hypertension Education Program) defined blood pressure targets. Additionally, the study assesses change in renal function (microalbuminuria, estimated glomerular filtration rate) in hypertensive participants treated with trandolapril (Mavik®) and examines patient satisfaction with trandolapril (Mavik®) therapy.


Condition
Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-interventional, Observational Study To Describe the Effectiveness of Trandolapril (Mavik®) in the Management of Patients Requiring Angiotensin Converting Enzyme Inhibitor Treatment (In-MAU-tion)

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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."


Enrollment: 7993
Study Start Date: December 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hypertensive Participants
Hypertensive diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction, who were naïve to trandolapril or on trandolapril within past 30 days.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinics

Criteria

Inclusion Criteria:

  • Adults capable of providing consent and who have uncontrolled hypertension
  • Participants were either treatment-naïve or had uncontrolled hypertension on their existing antihypertensive medication.

Exclusion Criteria:

  • Participants were excluded from participation in the study if they had been taking trandolapril (Mavik®), alone or in combination, for more than 1 month prior to enrollment.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078584

  Show 568 Study Locations
Sponsors and Collaborators
Abbott
McKesson Canada
Investigators
Study Director: Linda Assouline, PhD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01078584     History of Changes
Other Study ID Numbers: P10-665
Study First Received: March 1, 2010
Results First Received: September 7, 2012
Last Updated: October 19, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Abbott:
Uncontrolled hypertension
trandolapril

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Trandolapril
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014