Branded versus branded generic amlodipine in hypertension

Clinical effectiveness and safety of generic versus branded amlodipine in hypertension:a single blind, prospective, randomized, crossover, non-inferiority trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/01/005390

Enrollment

Registered

2015-01-13

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- essential Hypertension

Interventions

Intervention1: Branded generic of Amlodipine tablet: 5 mg tablet of amlodipine of a branded generic Intervention2: Generic of Amlodipine tablet: 5 mg tablet generic amlodipine obtained from fair price

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects with Stage-I Hypertension of JNC-7 Classification i.e. Systolic Blood Pressure (SBP) of 140-159 mm of hg or Diastolic Blood Pressure(DBP) of 90-99 mm of hg who were not receiving any antihypertensive in the last 1 week before screening OR Subjects with Isolated systolic hypertension as per JNC 7 Classification i.e. Systolic Blood Pressure (SBP) of >= 140 mm of hg and Diastolic Blood Pressure (DBP) of 2.Age >= 18 but 3.Subjects willing to give written informed consent and abide by all study related procedures

Exclusion criteria

Exclusion criteria: (1) Subjects with blood pressure values out of range (2) Past history of hypersensitivity to Amlodipine (3) Female subjects who are pregnant or lactating (4) Any clinical condition that may be considered as unsuitable for study inclusion (5) Presence of any clinical condition that is contraindicated for Amlodipine use (6) History of pre-existing liver diseases or renal diseases

Design outcomes

Primary

Measure	Time frame
1) Change from baseline to study end (6 weeks) of systolic blood pressure 2) Proportion of subjects experiencing at least one treatment emergent adverse event Timepoint: 1) Change from baseline to study end (6 weeks) of systolic blood pressure 2) Proportion of subjects experiencing at least one treatment emergent adverse event	—

Secondary

Measure	Time frame
1.Change from baseline to each visit of SBP 2.Changes from baseline to study end of DBPTimepoint: 1. Baseline to each visit (2, 4 and 6 week in each sequence) 2.Baseline to 6 weeks in each sequence	—

Countries

India

Contacts

Public ContactDR ALAK KUMAR DAS

Institute of Postgraduate Medical Education Research Kolkata

drsupchat@gmail.com09874306719

Outcome results

None listed

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