Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Amlodipine: 5 mg Tablet Given Orally once a day for 16 weeks.
Control Intervention1: S-Amlodipine: 2.5 mg Tablet Given Orally once a day for 16 weeks.
Sponsors
Indira Gandhi Government Medical College and Hospital, Nagpur.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 18 to 75 years 2. Diagnosed with grade I & II hypertension ( Systolic BP between 140-179 mmHg and/or Diastolic BP between 90-109 mmHg). 3. Patients who are able to comply with the study protocol ,attend scheduled visits ,willingness to participate in the study and provide informed consent. 4. OutPatient Department
Exclusion criteria
Exclusion criteria: 1.Previous History of myocardial infarction , PTCA , CABG, angina pectoris or cerebrovascular accidents in the last 6 months . 2.History of secondary or malignant hypertension 3.History of congestive cardiac failure , cardiac arrhythmias, any other abnormalities in ECG. 4.Patient with known significant respiratory conditions . 5. Patient with known significant Neurological diseases , Coagulation disorders , metabolic or endocrine disorder (except Type 2 Diabetes Mellitus) 6. Uncontrolled Diabetes Mellitus (fasting blood glucose more than 140 mg/dl ) or diabetic edema or Type 2 Diabetes Mellitus taking insulin or oral hypoglycemic drugs other than Metformin or sulfonylureas and more than one sulfonylureas. 7. Patient with Liver or Kidney disorder 8. Patients who may develop edema feet by concomitant drug at screening : a. Drugs that constrict intra renal blood vessels (eg. NSAIDS , Cyclosporine etc.) b. Drugs that dilate arterioles (eg .vasodilators etc) c. Drugs that increase sodium reabsorption in the kidneys (eg steroids) d.Drugs that damage capillaries (eg interleukins 2 ) e. Glitazone based drugs for diabetes 9.Known Hypersensitivity to CCBs. 10. Patients with psychiatric disorder . 11.Those who are taking the drugs that may cause drug interactions. a.Drugs that may change the plasma concentration of amlodipine (eg.CYP3A4 inducers -Rifampicin , St.johns wort) b.Drugs that may increase the antihypertensive action {(eg. other antihypertensives -CCBs , Beta blockers , ACEi , ARBs, Alpha blockers , diuretics , Ntg ),(TCAs- Amitriptyline , desipramine, imipramine, nortriptyline, protriptyline, trimipramine ),nitrate formulations ,baclofen , pioglitazone , sildenafil etc.} c. Systemic corticosteroids ( fluocinolone , triamcinolone) etc . : Local steroid application allowed. d.Drugs that may increase the inhibitory action of muscle contraction .( eg-antiarrhythmics -amiodarone, quinidine) etc. e.Drugs that may cause ventricular spasms (eg. intravenous administration of dantrolene and verapamil) f.Drugs that may increase the risk of hypotension (eg CYP3A4 inhibitors -clarithromycin ) etc. 12.Patients with a history of malignancy within the last 5 years. 13. Pregnant and lactating women or the women in the reproductive age group not practicing the effevtive means of contraception 14.Patients with known alcohol or drug abuse and any condition . 15.Patients in inpatient department. 16. Known case of immunodeficiency 17.Age less than 18 years and greater than 75 years 18.Participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change in the blood pressure at the end of 16 weeksTimepoint: Mean Change in the blood pressure will be estimated at baseline and 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Analyzing the cost-effective analysis of antihypertensive drug mentioned in the trialTimepoint: cost effective analysis will be done at baseline & 16 weeks.;Recording of adverse event, if any, according to the prescribed proforma issued by Pharmacovigilance program of India (PvPI).Timepoint: adverse drug reactions are noted at any point of time after drug intake | — |
Countries
India
Contacts
Public ContactDhwani Patel
Indira Gandhi Government Medical College and Hospital, Nagpur,
Outcome results
None listed