A study of Azelnidipine Tablets 16 mg for the treatment of hypertension

Phase 3

Not yet recruiting

• Conditions: Essential (primary) hypertension,

• Registration Number: CTRI/2018/10/015899
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

A Multicentric, Randomized, Double Blind, Parallel Group,Comparative, Phase III clinical study to evaluate the Efficacy, Safety andTolerability of Azelnidipine Tablets 16 mg Versus Amlodipine Tablets 10 mg insubjects with essential hypertension.

 PrimaryObjective: To evaluate the efficacy and safety of Azelnidipine Tablets 16 mg insubjects with essential hypertension.

 SecondaryObjective: To evaluate the tolerability of Azelnidipine Tablets 16 mg in subjectswith essential hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-24
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 228

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 ≤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.
• 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

• 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 hypertension	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 hypertension	Change from baseline in mean sitting DBP at the end of study (12 weeks).

Trial Locations

Locations (10)

Apex Hospital Pvt. Ltd; 🇮🇳 Jaipur, RAJASTHAN, India

Department of Medicine, Government Medical College & Hospital Nagpur; 🇮🇳 Nagpur, MAHARASHTRA, India

Gandhi Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Institute of Medical Sciences (IMS) and SUM Hospital; 🇮🇳 Cuttack, ORISSA, India

Institute of Post Graduate Medical Education and Research; 🇮🇳 Kolkata, WEST BENGAL, India

Medilink Hospital Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Osmania Medical College & General Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Post Graduate Department of Medicine, GSVM Medical College Kanpur; 🇮🇳 Nagar, UTTAR PRADESH, India

Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Redkar Hospital and Research Centre; 🇮🇳 Goa, GOA, India

Apex Hospital Pvt. Ltd

🇮🇳Jaipur, RAJASTHAN, India

Dr Brij Mohan Goyal

Principal investigator

9413190570

drbrijmohan.goyal@gmail.com