A Study of Combination of Azilsartan Medoxomil plus Cilnidipine Tablets for the treatment of subjects with Hypertension.

A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Azilsartan Medoxomil 40 mg plus Cilnidipine 5 mg Tablets and FDC of Azilsartan Medoxomil 40 mg plus Cilnidipine 10 mg Tablets versus Azilsartan Medoxomil Tablets 40 mg and Cilnidipine Tablets 10 mg monotherapy in subjects with stage 2 hypertension

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/07/020204

Enrollment

222

Registered

2019-07-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I10- Essential (primary) hypertension

Interventions

Intervention1: FDC of Azilsartan Medoxomil 40 mg plus Cilnidipine 5 mg Tablets: One tablet once a day orally in the morning after breakfast every day for 84 days (12 weeks) Intervention2: FDC of Azils

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female subjects aged between 18 and 65 years (both inclusive). 2. Treatment naÃ¯ve subjects diagnosed with stage 2 hypertension having mean seated 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. 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).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactAbhinav Arora

Synokem Pharmaceuticals Ltd.

abhinavarora@synokempharma.com9811882440

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026