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| Name | Class |
|---|---|
| MonitorCRO | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertensive patients | Hypertensive patients with elevated heart rate and type 2 diabetes mellitus |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in systolic blood pressure | mmHg | from baseline to week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in diastolic blood pressure (DBP) | mmHg | from baseline to week 8 |
| Ratio of patients achieving blood pressure ≤ 140 and/or 90 mmHg | from baseline to week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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State Hospital
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| Name | Affiliation | Role |
|---|---|---|
| Enver Atalar, Prof. Dr. | Hacettepe University Faculty of Medicine Hospital Cardiology Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research facility ID ORG-001108 | Adana | 01330 | Turkey (Türkiye) | |||
| Research facility ID ORG-001030 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32964020 | Derived | Atalar E, Eskin F, Tugtekin HB, Karabulut A, Kanyilmaz S, Kirbiyik H, Ozyildiz AG. A Prospective Noninterventional, Observational Study to Describe the Effectiveness and Safety of Trandolapril and Verapamil Single-Pill Combination in the Management of Patients with Hypertension and Type 2 Diabetes Mellitus: A Harvest TR Study. Biomed Res Int. 2020 Sep 5;2020:2123601. doi: 10.1155/2020/2123601. eCollection 2020. |
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| Ratio of responder patients (reduction of SBP ≥20 mmHg and/or DBP ≥10 mmHg) | from baseline to week 8 |
| Absolute change of heart rate | beat/min | from baseline to week 8 |
| 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 | ms. The PR interval indicates "atrioventricular conduction time". | from baseline to week 8 |
| The absolute change in HbA1c (if available) | from baseline to week 8 |
| The absolute change in microalbuminuria (if available) | mg/mmol | from baseline to week 8 |
| 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) | mmHg | from baseline to week 8 |
| Blood pressure variability (daily or hourly) in home blood pressure measurement | from baseline to week 8 |
| Ankara |
| 06230 |
| Turkey (Türkiye) |
| Yıldırım Beyazıt University Yenimahalle Training and Research Hospital | Ankara | 6170 | Turkey (Türkiye) |
| Research facility ID ORG-001111 | Antalya | 07059 | Turkey (Türkiye) |
| Research facility ID ORG-001120 | Aydin | 09020 | Turkey (Türkiye) |
| Research facility ID ORG-001119 | Aydin | 09100 | Turkey (Türkiye) |
| Research facility ID ORG-001116 | Balıkesir | 10000 | Turkey (Türkiye) |
| Research facility ID ORG-001112 | Burdur | 15300 | Turkey (Türkiye) |
| Research facility ID ORG-001123 | Çorum | 19200 | Turkey (Türkiye) |
| Erzurum Regional Training and Research Hospital | Erzurum | 25040 | Turkey (Türkiye) |
| Atatürk University Aziziye Research Hospital | Erzurum | 25080 | Turkey (Türkiye) |
| Research facility ID ORG-001118 | Istanbul | 34098 | Turkey (Türkiye) |
| Bakırköy Dr. Sadi Konuk Training and Research Hospital | Istanbul | 34147 | Turkey (Türkiye) |
| Research facility ID ORG-001117 | Istanbul | 34303 | Turkey (Türkiye) |
| Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Training and Research Hospital | Istanbul | 34668 | Turkey (Türkiye) |
| Research facility ID ORG-001125 | Istanbul | 34920 | Turkey (Türkiye) |
| Research facility ID ORG-001113 | Karabük | 78100 | Turkey (Türkiye) |
| Research facility ID ORG-001115 | Kirikkale | 71400 | Turkey (Türkiye) |
| Research facility ID ORG-001110 | Konya | 42250 | Turkey (Türkiye) |
| Research facility ID ORG-001122 | Trabzon | 61800 | Turkey (Türkiye) |
| Uskudar PublicHospital | Üsküdar | 34662 | Turkey (Türkiye) |
| Yalova Public Hospital | Yalova | 77000 | Turkey (Türkiye) |
| Research facility ID ORG-001124 | Zonguldak | 67900 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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