A study of Azelnidipine Tablets 16 mg for the treatment of hypertensio
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Registration Number
- CTRI/2018/10/015899
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Male or female subjects of age 18-65 years (both inclusive).
2.Treatment naïve subjects diagnosed with mean sitting SBP of >=160 to <=180 mm Hg and mean sitting DBP >=100 to <=110 mm Hg (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).
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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). <br/ ><br> <br/ ><br>Mean change in Ambulatory Blood Pressure (Mean 24 hour SBP and DBP) from baseline to the end of study (12 weeks) <br/ ><br>