Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Efonidipine Hydrochloride Ethanolate 20 mg and Telmisartan 40 mg: One tablet once a day orally in the morning after breakfast around same time for 12 weeks
Control Intervention1: Efonid
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following criteria will be recruited for the trial: 1. Male or Female subjects between 18 to 65 years of age (Both Inclusive). 2. Treatment-Naïve subjects who are suffering from Stage 2 Hypertension. 3. Subjects diagnosed with mean SBP of >=160 to =100 to 4. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
Exclusion criteria
Exclusion criteria: Subjects will be excluded if ANY of the following conditions apply: 1. Suspected hypersensitivity to any of the ingredients of study medication. 2. Subjects with known case of Secondary or Malignant Hypertension. 3. Subjects with abnormal Renal Function Test. 4. Subjects with abnormal eGFR less than 60 mL/min/1.73 m2 will be excluded from the study. 5. Subjects with known case of bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one functioning kidney. 6. Subjects with hyponatremia as per blood biochemistry results at screening. 7. Subjects with Serum potassium more than 5.5 mEq/L or less than 3.5 mEq/L at baseline. 8. Subjects with abnormal Liver Function Tests. 9. Subjects with abnormal Thyroid Function Test. 10. Subjects with known case of Type 1 Diabetes will be excluded from the study. 11. Subjects with Type 2 Diabetes Mellitus whose diabetes has not been stable and uncontrolled for the previous three months and with HbA1c value greater than 8% will be excluded from the study. 12. Subjects with known case of symptomatic congestive heart failure, severe aortic stenosis, unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery, sinus node dysfunction and any clinically significant cardiac arrhythmias will be excluded from the study. 13. Subjects with known case of Stroke will be excluded from the study. 14. Subjects diagnosed or suffering from any Oncological Conditions since last 2 years will be excluded from the study. 15. Subjects with known case of Epileptic seizures will be excluded from the study. 16. Subjects with clinical history of bipolar disorder i.e. who are taking lithium. 17. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the course of study. 18. Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent. 19. Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period. 20. Suspected inability or unwillingness to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy and safety of Efonidipine Hydrochloride Ethanolate 20 mg and Telmisartan 40 mg Tablets in Subjects with Stage 2 HypertensionTimepoint: Change from baseline in mean sitting SBP at the end of study (12 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the tolerability of Efonidipine Hydrochloride Ethanolate 20 mg and Telmisartan 40 mg Tablets in Subjects with Stage 2 Hypertension.Timepoint: Change from baseline in mean sitting DBP at the end of study (12 weeks). Mean change in Ambulatory Blood Pressure (Mean 24 hours SBP and DBP) from baseline to the end of study (12 weeks). | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Ajanta Pharma Ltd
Outcome results
None listed