Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male or Female patients with age 18 to 65 years. 2) Known cases of T2DM with HTN as Treatment naïve or uncontrolled receiving background ARB therapy for at least four weeks. 3) Patients with systemic blood pressure greater than equal 140/90 mmHg.
Exclusion criteria
Exclusion criteria: If patient meeting any of the study exclusion criteria should be excluded from study. 1) Patients with T1DM. 2) Patients with impaired hepatic function with liver enzymes 5X ULN. 3) Current state as pregnant or breast-feeding. 4) Patients not willing for follow up during the course of the study at 4W and 12W.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Change from baseline in Blood Pressure (SBP/DBP) 2) Change from baseline in Resting Heart Rate (RHR)Timepoint: Baseline, 4W and 12W | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change from baseline in LVEF. 2) Change from baseline in Sr. creatinine. 3) Change from baseline in UACR for cases with Diabetic Kidney Disease. 4) Change from baseline in Blood Pressure (SBP/DBP) with at least one additional risk factor like Dyslipidemia, Smoking, Family history or Comorbidity like Left ventricular dysfunction, chronic kidney disease with proteinuria less than 300 g/g OR 10y QRISK3 score more than 10%. 5) Change from baseline in Resting Heart Rate (RHR) for cases with 10y- QRISK3 score more than 10%.Timepoint: All assessments will be performed at baseline, 4W and 12W | — |
Countries
India
Contacts
Public ContactDr Rathish Nair PhD MBA
Torrent Pharmaceuticals Ltd
Outcome results
None listed