A multiple centre Phase III study of Azelnidipine in Newly Diagnosed Patients with Mild to Moderate Hypertension.

A Double Blind, Randomized, Multicentric, Active Controlled, Parallel Group, Comparative, Phase III study to evaluate the efficacy and safety of Azelnidipine versus Amlodipine in Newly Diagnosed Patients with Mild to Moderate Essential Hypertension.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/08/006136

Enrollment

600

Registered

2015-08-26

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: null- Newly Diagnosed patients with Mild to Moderate Essential Hypertension

Interventions

Intervention1: Azelnidipine: 8 mg Oral Tablet Dosage - One tablet per day in the morning orally after breakfast In case of inadequate response the dose would be escalated to 16 mg od. Duration of Ther

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or female patients of age between 18-65 years. 2.Patients or patientâ??s legally acceptable representative willing to sign the Informed Consent Form. 3.Patients newly diagnosed with mild to moderate Essential Hypertension with SBP ranging between 140-159 mmHg and/or DBP ranging between 90-99mmHg. 4.Patients willing and able to participate in all aspects of the core study, including use of oral medication, completion of subjective evaluations, and compliance with protocol requirements. 5.Female subjects of child bearing potential should have negative Urine Pregnancy Test (UPT) at the time of screening.

Exclusion criteria

Exclusion criteria: 1. Known or suspected secondary hypertension; severe diastolic hypertension (seated diastolic BP: >114 mm Hg) 2. Clinically significant renal (estimated glomerular filtration rate: 3. Clinically relevant or unstable cardiovascular diseases 4. Type 1 or poorly controlled type 2 diabetes mellitus (hemoglobin A1c: >=9%). 5. Night-shift workers 6. Pregnant or nursing women 7. Women of childbearing potential not using medically approved means of contraception 8. Patients taking any concomitant medications known to affect BP. 9. History of drug or alcohol abuse 10. Those who smoke >1 pack of cigarettes per day 11. Those with any medical condition judged by investigators to possibly jeopardize the evaluation of efficacy and safety of therapy were excluded from the study.

Design outcomes

Primary

Measure	Time frame
The primary end point for assessing efficacy will be the mean reduction in SBP and DBP at the end of 6 monthsTimepoint: Baseline, 30 days, 60 days, 120 days, 180 days	—

Secondary

Measure	Time frame
a) Percentage of patients reaching the defined blood pressure (BP) goal (140/90â??mmHg for general population, and 150/90â??mmHg for elderly) at the end of the study. b) % patients continuing with 8 mg Azelnidipine c) % patients uptitrated to 16 mg Azelnidipine d) % patients who require HCTZ to be added e) Mean change in the general and systemic examination from baseline to Day 30Â±2, Day 60Â±2, Day 120Â±2, Day 180Â±2.Timepoint: Baseline, 180 days	—

Measure

Time frame

a) Percentage of patients reaching the defined blood pressure (BP) goal (140/90â??mmHg for general population, and 150/90â??mmHg for elderly) at the end of the study. b) % patients continuing with 8 mg Azelnidipine c) % patients uptitrated to 16 mg Azelnidipine d) % patients who require HCTZ to be added e) Mean change in the general and systemic examination from baseline to Day 30Â±2, Day 60Â±2, Day 120Â±2, Day 180Â±2.Timepoint: Baseline, 180 days

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Countries

India

Contacts

Public ContactDr Manjusha Patankar

Clinical Medicine Infomatics India Pvt. Ltd.

cmiphase3@gmail.com08689901144

Outcome results

None listed

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