A clinical trial to study the effects and safety of two drugs, amlodipine and s-amlodipine in patients with mild to moderate blood pressure for 16 weeks
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Registration Number
- CTRI/2024/05/068049
- Lead Sponsor
- Indira Gandhi Government Medical College and Hospital, Nagpur.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method