Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: FDC of Benidipine 4 mg plus Telmisartan 40 mg Tablets: One tablet once a day orally in the morning after breakfast every day for 84 days (12 weeks)
Intervention2: FDC of Benidipine 4 mg
Sponsors
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged between 18 and 65 years (both inclusive). 2. Treatment naïve subjects diagnosed with stage 2 hypertension having mean seated SBP of >=160 to =100 to 3. Subjects with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 4. Subjects willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation. 2. Any surgical or medical condition which might alter the absorption, distribution, metabolism or excretion of the study drug. 3. Has clinical laboratory evaluations (including biochemistry and hematology) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator. 4. Subjects with known case of Secondary or Malignant Hypertension. 5. Subjects with evidence of postural hypotension (defined as drop in more than 20 mg of Hg for systolic blood pressure and morethan 10 mm of Hg for diastolic blood pressure after assuming the standing posture from supine or sitting position). 6. Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, sinus node dysfunction and any clinically significant cardiac arrhythmias. 7. Subject who has had myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery in last 1 year. 8. Subjects with known case of Stroke. 9. Subjects with abnormal Renal Function Test (RFT). 10. Subjects with abnormal eGFR (less than 60 mL per min per 1.73 m2). 11. 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. 12. Subjects with hyponatremia as per blood biochemistry results at screening. 13. Subjects with hyperkalemia and hypokalemia as per blood biochemistry results at screening. 14. Subjects with abnormal Liver Function Tests (Total bilirubin, SGOT & SGPT) with values more than 2.5 times the upper limit of normal. 15. Subjects with abnormal Thyroid Function Test (TSH) 16. Subjects with known case of Type 1 Diabetes. 17. Subjects with Type 2 Diabetes Mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than 8%. 18. Subjects with medical history of Oncological Conditions since last 2 years. 19. Subjects with known case of Epileptic seizures. 20. Subjects with clinical history of bipolar disorder i.e. who are taking lithium. 21. Subjects with known case of HIV, Hepatitis B & C. 22. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. 23. Females who are not ready to use acceptable contraceptive methods during the course of study. 24. Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent. 25. Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period. 26. Suspected inability or unwillingness to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in seated systolic blood pressure (SeSBP) between baseline and 12 weeks. [For subjects who are discontinued due to lack of efficacy last SBP reading at the time of discontinuation will be considered as end point].Timepoint: At Baseline, Week 1, Week 2, Week 4, Week 8 and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in ambulatory blood pressure (Mean 24 hour SBP and DBP) from baseline to the end of study (12 weeks).Timepoint: At Baseline and Week 12;Mean change in seated diastolic blood pressure (SeDBP) between baseline and 12 weeks. [For subjects who are discontinued due to lack of efficacy last DBP reading at the time of discontinuation will be considered as end point].Timepoint: At Baseline, Week 1, Week 2, Week 4, Week 8 and Week 12;The assessment of safety of subjects [comparison of incidence of treatment emergent adverse event (TEAE)].Timepoint: At Week 1, Week 2, Week 4, Week 8 and Week 12;The assessment of tolerability of investigational product will be based on incidence of AEs and SAEs and changes in laboratory values.Timepoint: At Week 1, Week 2, Week 4, Week 8 and Week 12 | — |
Countries
India
Contacts
Public ContactRahul Vij
Synokem Pharmaceuticals Ltd.
Outcome results
None listed