Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Azelnidipine and Chlorthalidone: A) Azelnidipine 8mg + Chlorthalidone 6.25 mg and
B) Azelnidipine 8mg + Chlorthalidone 12.5 mg
Dosage- 1 tablet to be taken daily, orally with plain wa
Sponsors
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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. 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. 3. Subjects with known case of Secondary or Malignant Hypertension. 4. Subjects with evidence of postural hypotension (defined as drop in >20 mmHg for systolic blood pressure and >10 mmHg for diastolic blood pressure after assuming the standing posture from supine or sitting position). 5. Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, sinus node dysfunction and any clinically significant cardiac arrhythmias. 6. Subject who has had myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery in last 1 year. 7. Subjects with known case of Stroke. 8. Subjects with abnormal eGFR ( 9. 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. 1 10. Subjects with hyponatremia as per blood biochemistry results at screening. 11. Subjects with hyperkalemia and hypokalemia as per blood biochemistry results at screening. 12. Subjects with abnormal Liver Function Tests (Total bilirubin, SGOT & SGPT) with values more than 2.5 times the upper limit of normal. 13. Subjects with abnormal Thyroid Function Test (TSH). 14. Subjects with Type 1 diabetes & Type 2 diabetes mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than 8%. 15. Subjects with medical history of Oncological Conditions since last 5 years. 16. Subjects with known case of Epileptic seizures. 17. Subjects with clinical history of bipolar disorder. 18. Subjects with known case of HIV, Hepatitis B & C. 19. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. 20. Females who are not ready to use acceptable contraceptive methods during the course of study. 21. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent. 22. Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period. 23. Suspected inability or unwillingness to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability of the FDCs will be assessed by the Clinical AEs, including laboratory abnormalitiesTimepoint: Day 1, Week 2, Week 4, Week 8 and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Difference in mean change in SBP from baseline at the end of 12 weeks between each FDC group 2. Difference in mean change in DBP from baseline at the end of 12 weeks between each FDC group Timepoint: Testing Intervals: Day 1, Week 2, Week 4, Week 8 and Week 12 | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
Innovate Research
Outcome results
None listed