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Comparison of Two Medicines (Benidipine and Amlodipine) for Controlling Blood Pressure and their Side Effects in People with Newly Diagnosed High Blood Pressure

A Prospective, Parallel-Group, Open-Label Study to Compare the Effectiveness and Safety of Benidipine and Amlodipine in Newly Diagnosed Patients with Hypertension - BAM-HYP Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109347
Enrollment
70
Registered
2026-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: I10-I16- Hypertensive diseases

Interventions

Intervention1: Benidipine: Group B: Participants would receive Benidipine Monotherapy of 4 mg/day orally in morning for 90 days. Control Intervention1: Amlodipine: Group A: Participants would receive

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Newly diagnosed hypertensive patients as per Indian Society of Hypertension latest guidelines visiting the Medicine OPD. 2.Patients of either sex between 30 and 75 years of age. 3.Patients willing to join the study after giving the written informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients diagnosed with secondary hypertension. 2.Patients with pre-existing cardiovascular complications (e.g., stroke, congestive heart failure). 3.Patients on concomitant medications known to significantly interact with calcium channel blockers (CCBs), such as non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, CNS stimulants. 4.Patients with severe renal, hepatic, or other systemic diseases affecting vital organ function. 5.Patients presenting with pedal edema, hypoproteinemia or anemia at baseline. 6.Pregnant or lactating women. 7.Patients with known contraindications or hypersensitivity to amlodipine or benidipine. 8.Patients unwilling to adhere to the study protocol or provide written consent.

Design outcomes

Primary

MeasureTime frame
To compare reduction in SBP and DBP between Benidipine and AmlodipineTimepoint: Baseline,4 weeks,8 weeks,12 weeks

Secondary

MeasureTime frame
To compare proportion of patients achieving target BP less than 130upon85 mmHgTimepoint: Baseline, 12weeks;To compare incidence of adverse drug reactionsTimepoint: Baseline,4 weeks,8 weeks,12 weeks

Countries

India

Contacts

Public ContactDr Abhinav Dhiman

Government Medical College, Amritsar

navyug69@gmail.com9878634358

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026