A clinical study to assess the efficacy and safety of combination of Azilsartan and Amlodipine Tablets in patients with hypertension.
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Registration Number
- CTRI/2022/02/040081
- Lead Sponsor
- Inventia Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 309
1. Male or Female patients between 18 to 65 years of age (both inclusive).
2. Treatment-Na�¯ve patients who are suffering from Stage 2 Hypertension.
3. Patients diagnosed with mean sitting SBP of �160 to �180 mmHg and mean sitting DBP �100 to �110 mmHg (3 readings will be taken by validated automated blood pressure machine in sitting position, first reading will be taken after 15 min. rest and subsequent two readings will be recorded at the interval of 2 min. each).
4. Patients who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
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. Patients with known case of secondary or malignant hypertension.
4. Patients with evidence of postural hypotension (defined as drop in >20 mg of Hg for systolic blood pressure and >10 mm of Hg for diastolic blood pressure after assuming the standing posture from supine or sitting position).
5. Patients with known case of symptomatic congestive heart failure, unstable angina pectoris, sinus node dysfunction and any clinically significant cardiac arrhythmias.
6. Patient who has had myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery in last 1 year.
7. Patients with known case of stroke.
8. Patients with abnormal eGFR ( <60 mL/min/1.73 m2).
9. Patients with known case of bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one functioning kidney.
10. Patients with hyponatremia as per blood biochemistry results at screening.
11. Patients with hyperkalemia and hypokalemia as per blood biochemistry results at screening.
12. Patients with clinically significant impaired hepatic function [SGOT & SGPT more than 2.5X the UNL and Total bilirubin more than 1.5X the UNL].
13. Patients with abnormal thyroid function test (TSH).
14. Patients with known case of type 1 diabetes and 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. Patients with medical history of any oncological conditions.
16. Patients with known case of epileptic seizures.
17. Patients with clinical history of bipolar disorder.
18. Patients with known case of HIV, hepatitis B & C.
19. Pregnant or lactating women.
20. Women of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception [which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, some IUDs, sexual abstinence or vasectomised partner, during the study therapy.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in mean sitting systolic blood pressure (MSSBP) at the end of study (12 weeks).Timepoint: At Screening Visit (Visit 1), <br/ ><br>Visit 3 / Day 14, <br/ ><br>Visit 4 / Day 28, <br/ ><br>Visit 5 / Day 56 and <br/ ><br>Visit 6 / Day 84
- Secondary Outcome Measures
Name Time Method Change from baseline in mean sitting diastolic blood pressure (MSDBP) at the end of study (12 weeks).Timepoint: At Screening Visit (Visit 1), <br/ ><br>Visit 3 / Day 14, <br/ ><br>Visit 4 / Day 28, <br/ ><br>Visit 5 / Day 56 and <br/ ><br>Visit 6 / Day 84;Mean change in Ambulatory Blood Pressure (Mean 24 hour SBP and DBP) from baseline to the end of study (12 weeks).Timepoint: At Screening Visit (Visit 1) and <br/ ><br>Visit 6 / Day 84;The assessment of safety of Patients (comparison of incidence of treatment emergent adverse event (TEAE)).Timepoint: At Visit 3 / Day 14, <br/ ><br>Visit 4 / Day 28, <br/ ><br>Visit 5 / Day 56 and <br/ ><br>Visit 6 / Day 84;The assessment of tolerability of Investigational Product will be based on incidence of AEs and SAEs and Changes in laboratory values.Timepoint: At Visit 3 / Day 14, <br/ ><br>Visit 4 / Day 28, <br/ ><br>Visit 5 / Day 56 and <br/ ><br>Visit 6 / Day 84