A Study of Combination of Azilsartan Medoxomil plus Cilnidipine Tablets for the treatment of subjects with Hypertension.
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Registration Number
- CTRI/2019/07/020204
- Lead Sponsor
- Synokem Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 228
1. 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 <=180 mmHg and mean seated 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).
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. Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
2. Any surgical or medical condition which might alter the absorption, distribution, metabolism or excretion of the 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. Subjects with known case of secondary or malignant hypertension.
5. 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in seated systolic blood pressure (SeSBP) between baseline and 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]Timepoint: At Baseline, Week 2, Week 4, Week 8 and Week 12
- Secondary Outcome Measures
Name Time Method Mean change in ambulatory blood pressure (Mean 24 hour SBP and DBP) from baseline to the end of study (12 weeks)Timepoint: At baseline and Week 12;Mean change in seated diastolic blood pressure (SeDBP) between baseline and 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]Timepoint: At Baseline, Week 2, Week 4, Week 8 and Week 12