Effect of Amlodipine on the Lipid Profile of Newly Diagnosed Hypertensive Patients

Study Overview
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Brief Summary
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In this study, Amlodipine has been used to study its effects in newly diagnosed hypertensive patients.

Detailed Description
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The incidence of hypertension is on the rise in developing countries like Pakistan. Different medications are used to decrease blood pressure with Amlodipine as one of the first-line drugs. It was proposed that due to interaction with calcium and thus luminal cholecystokinin releasing factor; Amlodipine might increase the cholesterol level and thus cause dyslipidemia. Objective: In this regard, this study was conducted to look into the effects of Amlodipine in newly diagnosed cases of hypertension that had received no medication previously. Methodology: Experimental study with a healthy control group with the sample size calculated out to be 80, comprising of an equal number of enrolment into case and control groups.

Official Title
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Effect of Amlodipine on the Lipid Profile of Newly Diagnosed Hypertensive Patients

Conditions
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Hypercholesterolemia, Hypertension, Cholesterol Deposition

Intervention / Treatment
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* Drug: Amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for cases. 1) Newly diagnosed mild to moderate hypertensive. (2) Non-obese individuals. 3) Must not have received antihypertensive treatment previously. 4) Has elevated serum cholesterol levels. Exclusion criteria for cases 1) Any other major illness. Inclusion criteria for controls Normal lipid profile. Normotensive (BP < 140/90mmHg). Exclusion criteria for controls 1) Any major illness.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Case with healthy control
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Newly Diagnosed Hypertensive patients<br>These are the patients that have been clearly diagnosed with diabetes for the first time. | Drug: Amlodipine<br>* 5mg/day in two divided doses<br>* Other names: Norvasc;|
| No Intervention: Healthy Controls<br>Healthy Control Group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Blood Glucose Concentration | Measured as per protocols provided by the kit manufacturer. | Four Months | 
| Measurement of Total Plasma Cholesterol Concentration | Measured as per protocols provided by the kit manufacturer. | Four Months | 
| Measurement of Plasma Triglyceride Concentration | Measured as per protocols provided by the kit manufacturer. | Four Months | 
| Measurement of Plasma High Density Lipoproteins Concentration | Measured as per protocols provided by the kit manufacturer. | Four Months | 
| Measurement of Plasma Low Density Lipoproteins Concentration | Measured as per protocols provided by the kit manufacturer. | Four Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Hypercholesterolemia