Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Azelnidipine Tablets 16 mg: Each tablet is to be taken orally with water in the morning after breakfast preferably on the same time every day. Thus the subject will receive the drug tre
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects of age 18-65 years (both inclusive). 2. Treatment naïve subjects diagnosed with mean sitting 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. Subjects with known hypersensitivity to any of the components of the formulation. 2. Any surgical or medical condition which might alter the absorption, distribution, metabolism or excretion of 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. Cardiovascular system: • Known case of secondary or malignant hypertension. • 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 and any clinically significant cardiac arrhythmias.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy and safety of Azelnidipine Tablets 16 mg in subjects with essential hypertensionTimepoint: Change from baseline in mean sitting SBP to the end of study (12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the tolerability of Azelnidipine Tablets 16 mg in subjects with essential hypertensionTimepoint: Change from baseline in mean sitting DBP at the end of study (12 weeks). Mean change in Ambulatory Blood Pressure (Mean 24 hour 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