Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: FDC of Telmisartan 40/80 mg
and Amlodipine 5mg: 1 tablet to be taken once daily,
orally with plain water after
meal, daily for 365 days.
Control Intervention1: FDC of Telmisartan 40/80
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged between 18 to 75 years 2. Subjects with the ability to understand and provide written informed consent forms which must have been obtained prior to screening. 3. Subjects with hypertension (systolic/diastolic BP more than or equal to 130/80 and less than 180/110 mmHg 4. Subjects with hypertension and renal impairment eGFR more than or equal to 60 ml/min/1.73m2 and urinary albumin in the range of 30â??600 mg/g creatinine 5. Subjects with hypertension requiring antihypertensive treatment with two drug therapy 6. Subjects on a stable dose of antihypertensive treatment with Telmisartan for more than or equal to 3 months before the enrolment; 7. Subjects not on CCB treatment for their hypertension management for more than or equal to 3 months before the enrolment 8. Subjects willing to comply with the protocol requirements
Exclusion criteria
Exclusion criteria: 1. Presence of any clinically relevant disease/disorder (e.g., severe hepatic impairment, chronic renal failure, thromboembolic disorders, coronary artery or cerebrovascular diseases, uncontrolled diabetes (HbA1c more than or equal to 7%), uncontrolled thyroid disorder etc.) 2. Causes of renal disease other than hypertension or T2DM 3. Urinary tract infections 4. Acute Kidney Injury (AKI) 5. Subjects of T1DM 6. Subjects of T2DM diagnosed more than 1 year prior to screening 7. Severe hypertension (more than or equal to 180/110 mmHg) 8. Serum creatinine more than or equal to 2.0 mg/dL in men or more than or equal to1.5 mg/dL in women 9. Subjects, in the opinion of investigators, requiring initiation of treatment with initial monotherapy 10. Surgical or medical condition that, in the judgment of the Investigator, could interfere with the absorption, distribution, metabolism, or excretion of the drugs to be used. 11. Presence or history of secondary or malignant hypertension. 12. Any known cardiac disease/disorder in which any of the study medications is contra-indicated. 13. Current or recent substance abuse, including alcohol. 14. Refusal or inability to comply with the requirements of the protocol for any the reason, including scheduled clinic visits and laboratory tests. 15. Participation in any experimental drug study within 60 days before screening. 16. Breast feeding or pregnant females or Females with child-bearing potential who do not follow adequate contraceptive measures. 17. Concomitant or prior (within 60 days of screening) use of any of the following medications: calcium channel blocker, clonidine, aliskerin. 18. Subjects having intolerance, hypersensitivity or any other contraindication to any of the Investigational products. 19. History of HIV, Hepatitis B and Hepatitis C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in urinary albumin-creatinine ratio (UACR)Timepoint: Time Frame: Day 0, Day 180 & Day 365 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate and compare the effect of Telmisartan plus Amlodipine Vs. Telmisartan plus Cilnidipine in subjects suffering from hypertension and renal impairment by the- â?¢ Change from baseline in estimated glomerular filtration rate (eGFR) at Week 52 â?¢ Change from baseline in office blood pressure at Week 52 â?¢ Change from baseline in serum creatinine levels at Week 52 â?¢ Change from baseline in serum uric acid levels at Week 52 To evaluate and compare the safety of Telmisartan plus Amlodipine Vs. Telmisartan plus Cilnidipine in subjects suffering from hypertension and renal impairment by the- â?¢ Incidence of adverse effects of Telmisartan plus Amlodipine Vs. Telmisartan plus Cilnidipine at follow up visits of treatment Timepoint: Time Frame: Day 0, Day 180 & Day 365 | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
Glenmark Pharmaceuticals Ltd.
Outcome results
None listed