N/A
Completed N=7,993
Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients
Source: ClinicalTrials.gov NCT01078584 ↗Enrolled (actual)
7,993
Serious AEs
1.0%
Results posted
Oct 2012
Primary outcomePrimary: Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 3 Months — 56.0; 28.2 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 3 Months |
56.0; 28.2 | — |
| PRIMARY Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 6 Months |
66.2; 31.1 | — |
| PRIMARY Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 12 Months |
72.9; 34.4 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 3 Months |
0.7; -1.5; 1.7 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 6 Months |
0.0; 0.7; -0.4 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 12 Months |
0.8; 1.5; 0.4 | — |
| SECONDARY Change From Baseline in Microalbuminuria (MAU) at 3 Months |
-6.8 | — |
| SECONDARY Change From Baseline in Microalbuminuria (MAU) at 6 Months |
-5.3 | — |
| SECONDARY Change From Baseline in Microalbuminuria (MAU) at 12 Months |
-6.9 | — |
| SECONDARY Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 3 Months of Therapy |
58.4 | — |
| SECONDARY Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 6 Months of Therapy |
67.6 | — |
| SECONDARY Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 12 Months of Therapy |
74.2 | — |
| SECONDARY Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy |
28.4; 26.8; 30.7; 10.3; 3.8; 1.8 | — |
| SECONDARY Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy |
0.62; 0.67; 2.33; 8.36; 15.63; 0.42 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01078584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.