Hypertension
Conditions
Keywords
Hypertension, Diabetes Mellitus, ACE Inhibitors, Calcium Channel Blockers
Brief summary
To describe the effectiveness of angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination on systolic blood pressure (SBP) lowering in hypertensive patients with elevated heart rate and type 2 diabetes
Interventions
None listed
Sponsors
MonitorCRO
Abbott
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female * ≥ 18 years old * Has been already diagnosed with hypertension * Has been already diagnosed with type 2 diabetes mellitus * Started using angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination within a maximum of 1 week before enrolment * Heart rate ≥70 beat per minute
Exclusion criteria
* Pregnant or breast feeding female * Current need to use any other antihypertensive drug(s) in addition to angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination * Having any contraindication for angiotensin-converting enzyme inhibitor or non-dihydropyridine calcium channel blocker; * Has been treated by any anti-hypertensive treatment(s) before angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination * Is currently participating in another clinical or non-clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change in systolic blood pressure | from baseline to week 8 | mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of patients achieving blood pressure ≤ 140 and/or 90 mmHg | from baseline to week 8 | — |
| Ratio of responder patients (reduction of SBP ≥20 mmHg and/or DBP ≥10 mmHg) | from baseline to week 8 | — |
| Absolute change of heart rate | from baseline to week 8 | beat/min |
| Correlation between absolute change in blood pressure and absolute change in heart rate | from baseline to week 8 | — |
| The absolute change in PR interval on electrocardiography | from baseline to week 8 | ms. The PR interval indicates atrioventricular conduction time. |
| Absolute change in diastolic blood pressure (DBP) | from baseline to week 8 | mmHg |
| The absolute change in microalbuminuria (if available) | from baseline to week 8 | mg/mmol |
| The ratio of patients experiencing an adverse event including the nature of the adverse event/severe adverse event | from baseline to week 8 | — |
| The correlation between physician's office and home blood pressure measurements (Difference in medians) | from baseline to week 8 | mmHg |
| Blood pressure variability (daily or hourly) in home blood pressure measurement | from baseline to week 8 | — |
| The absolute change in HbA1c (if available) | from baseline to week 8 | — |
Countries
Turkey (Türkiye)
Outcome results
None listed