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

Phase 3

Completed

• Conditions: Essential (primary) hypertension,

• Registration Number: CTRI/2019/07/020204
• Lead Sponsor: Synokem Pharmaceuticals Ltd

Brief Summary

A Multicentric, Randomized, Double Blind, ParallelGroup, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safetyand Tolerability of FDC of Azilsartan Medoxomil 40 mg + Cilnidipine 5 mgTablets and FDC of Azilsartan Medoxomil 40 mg + Cilnidipine 10 mg Tabletsversus Azilsartan Medoxomil Tablets 40 mg and Cilnidipine Tablets 10 mg monotherapyin subjects with stage 2 hypertension.

 **Primary objective:** To evaluate theefficacy and safety of FDC of AzilsartanMedoxomil 40 mg + Cilnidipine 5 mg Tablets and FDC of Azilsartan Medoxomil 40 mg + Cilnidipine 10 mg Tabletsin subjects with stage 2 hypertension.

**Secondary objective:** To evaluate thetolerability of FDC of AzilsartanMedoxomil 40 mg + Cilnidipine 5 mg Tablets and FDC of Azilsartan Medoxomil 40 mg + Cilnidipine 10 mg Tabletsin subjects with stage 2 hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-22
• Study Completion: 2020-01-18
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

• Male or female subjects aged between 18 and 65 years (both inclusive).
• 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.
• Subjects with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
• Subjects willing to comply with the protocol requirements.

Exclusion Criteria

• Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
• Any surgical or medical condition which might alter the absorption, distribution, metabolism or excretion of the study drug.
• 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.
• Subjects with known case of secondary or malignant hypertension.
• 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]	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)	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]	At Baseline, Week 2, Week 4, Week 8 and Week 12

Trial Locations

Locations (24)

Aman Hospital & Research Center; 🇮🇳 Vadodara, GUJARAT, India

Bansal Hospital & Research Centre; 🇮🇳 Jaipur, RAJASTHAN, India

Down Town Hospital Ltd.; 🇮🇳 Kamrup, ASSAM, India

Gandhi Hospital; 🇮🇳 Hyderabad, TELANGANA, India

GCS Medical College, Hospital and Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

GNRC Hospitals; 🇮🇳 Kamrup, ASSAM, India

GSVM Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

Health Point Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

IPGME&R and SSKM Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Janam Multi-Specialty Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Scroll for more (14 remaining)

Aman Hospital & Research Center

🇮🇳Vadodara, GUJARAT, India

Dr Aman Romesh Khanna

Principal investigator

9904402122

amankhanna1974@gmail.com