Clinical Study on Fixed Dose Combination of S-amlodipine besylate and Clopidogrel bisulphate Tablet

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/003032

Enrollment

100

Registered

2010-11-30

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

None listed

Interventions

Intervention1: Fixed Dose Combination of S (-) Amlodipine besylate (2.5 mg / 5 mg) with Clopidogrel bisulphate (75 mg) tablet: orally once daily Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: Male or female subjects between 40-65 years of age. Subjects with hypertension Subjects with ischemic heart disease (IHD) / diabetes mellitus / peripheral vascular disease OR subjects with previous history of cerebrovascular accident OR subjects who are at high risk for atherothrombotic events Subject willing to give written informed consent and willing to comply with study protocol

Exclusion criteria

Exclusion criteria: Subjects previously sensitive to Amlodipine, S-Amlodipine, Clopidogrel, or to any of the ingredients of the fixed dose combination under study. Subjects with Hypertension, requiring antihypertensive therapy other than Amlodipine. Subjects with history of secondary or Malignant Hypertension. Subjects requiring multidrug antihypertensive therapy. Subjects with cardiac arrhythmia or any abnormality on ECG. Patients with significant respiratory/liver/kidney/neurological/ metabolic or endocrinal disorder (excluding type 2 Diabetes Mellitus) diseases Patients with active pathological bleeding OR history of bleeding tendencies or bleeding disorders. Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception. Patients who will receive some other drug during the study besides that in the protocol that could alter the pharmacokinetic/ pharmacodynamic profile of the study drug. Patients with Alcohol or drug abuse. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.

Design outcomes

Primary

Measure	Time frame
1) Control of blood pressure 2) Any cardiovascular/ atherothrombotic event 3) Subject?s global assessment about the tolerability of the drug 4) Physician?s global assessment about the tolerability of the drug 5) Percent of the subjects experiencing any drug related adverse event as evaluated and recorded by the investigator 6) CBC (Complete Blood Count), LFT (Liver Function Test), KFT (Kidney Function Test) Lipid profile, FBG (Fasting Blood Glucose), and ECG (Electrocardiogram)Timepoint: Day 0 and after 4, 8 and 12 weeks of therapy. Global assessment will be done after 12 weeks of therapy. Investigations will be done at day 0 and after 12 weeks of therapy	—

Measure

Time frame

1) Control of blood pressure 2) Any cardiovascular/ atherothrombotic event 3) Subject?s global assessment about the tolerability of the drug 4) Physician?s global assessment about the tolerability of the drug 5) Percent of the subjects experiencing any drug related adverse event as evaluated and recorded by the investigator 6) CBC (Complete Blood Count), LFT (Liver Function Test), KFT (Kidney Function Test) Lipid profile, FBG (Fasting Blood Glucose), and ECG (Electrocardiogram)Timepoint: Day 0 and after 4, 8 and 12 weeks of therapy. Global assessment will be done after 12 weeks of therapy. Investigations will be done at day 0 and after 12 weeks of therapy

—

Secondary

Measure	Time frame
NoneTimepoint: None	—

Countries

India

Contacts

Public ContactDr. Onkar Swami, MD

Emcure Pharmaceuticals Ltd.

Onkar.Swami@emcure.co.in020-39821000

Outcome results