Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Azelnidipine 16 mg plus Telmisartan 40 mg Film Coated Tablets: One tablet once a day orally in the morning after breakfast around same time every day
Intervention2: Azelnidipine 16 mg p
Sponsors
Mascot Health Series PVT Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female subjects of age 18 to 65 years (both inclusive). 2. Treatment-Naïve subjects diagnosed with Stage 2 Hypertension having mean SBP of >=160 to =100 to 3. Subjects with the ability to understand and provide a written informed consent form, which must have been obtained before the screening. 4. Subjects willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Suspected hypersensitivity to either the study medications or any of the formulation ingredients. 2. Subjects with a medical history of oncological conditions for the last 2 years. 3. Subjects with known cases of Epileptic seizures, clinical history of bipolar disorder i.e. who are taking lithium. 4. Patients suspected to be addicted to alcohol or drug abuse or with severe complications that would make the condition more complicated were assessed by the investigator. 5. Subject having any disease/ abnormalities as follow, Cardiovascular system: • Subject with unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery, and any clinically significant cardiac arrhythmias. • Subjects with known cases of Secondary or Malignant Hypertension. • Subjects with known cases of symptomatic congestive heart failure, severe aortic stenosis. Endocrine system: • Subjects with abnormal Thyroid Function Test (TSH) [Normal range is 0.45 to 4.5 mIU/mL]. • Subjects with Type 1 Diabetes Mellitus. • Subjects with Type 2 Diabetes Mellitus whose diabetes has not been stable and controlled for the previous three months and with an HbA1c value greater than 8%. Renal system: • Subjects with hyperkalemia and hypokalemia as per blood biochemistry results at screening [Normal range 3.5 to 5.5 mEq/L. • Subjects with hyponatraemia as per blood biochemistry results at screening [Normal range 135 to 145 mEq/L]. • Subjects with abnormal Renal Function Test (RFT) [Serum Creatinine Normal range 0.6 to 1.3 mg/dL] & [BUN Normal range 7 to 20 mg/dL]. • Subjects with abnormal eGFR ( • Subjects with known cases of bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant, or with only one functioning kidney. Hepatic system: • Subjects with abnormal Liver Function Tests with values more than 2.5 times the upper limit of normal. 6. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. 7. Females who are not ready to use acceptable contraceptive methods during study. 8. Concurrent participation in another clinical trial or any investigational therapy within 30 days before signing informed consent. 9. Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period. 10. Suspected inability or unwillingness to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in mean sitting SBP to the end of study (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]. 2. The assessment of safety of Subjects (comparison of incidence of treatment emergent adverse event (TEAE)).Timepoint: 1. Change from baseline in mean sitting SBP to the end of study (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]. 2. The assessment of safety of Subjects (comparison of incidence of treatment emergent adverse event (TEAE)). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in mean sitting DBP at the end of study (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]. 2. Mean change in Ambulatory Blood Pressure (12 weeks) (Approximately for 25% of study population). 3. The assessment of tolerability of Investigational Product will be based on incidence of AEs and SAEs and Changes in laboratory values.Timepoint: Change from baseline in mean sitting DBP at the end of study (12 weeks). | — |
Countries
India
Contacts
Public ContactDr Ravindra Mote
Mascot Health Series Pvt. Ltd.
Outcome results
None listed