Clinical Study on Fixed Dose Combination of S-amlodipine besylate and Clopidogrel bisulphate Tablet
- Registration Number
- CTRI/2010/091/003032
- Lead Sponsor
- Emcure Pharmaceuticals Ltd, Pune.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method