Clinical trial NCT05467384: Effect of Amlodipine on the Lipid Profile of Newly Diagnosed Hypertensive Patients
Official title: Effect of Amlodipine on the Lipid Profile of Newly Diagnosed Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Hypertension
Cholesterol Deposition
Keywords: Hypercholesterolemia
Hypertension
Lead sponsor: Ayub Teaching Hospital
Sponsor class: OTHER
Collaborators: name: Khyber Medical University Peshawar
First posted: 2022-07-20
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case with healthy control
Primary purpose: TREATMENT

Brief summary: In this study, Amlodipine has been used to study its effects in newly diagnosed hypertensive patients.

Detailed description: 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.

Eligibility criteria: 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

1. Normal lipid profile.
2. Normotensive (BP \< 140/90mmHg). Exclusion criteria for controls

1) Any major illness.

Primary outcomes:
measure: Measurement of Blood Glucose Concentration
timeFrame: Four Months
measure: Measurement of Total Plasma Cholesterol Concentration
timeFrame: Four Months
measure: Measurement of Plasma Triglyceride Concentration
timeFrame: Four Months
measure: Measurement of Plasma High Density Lipoproteins Concentration
timeFrame: Four Months
measure: Measurement of Plasma Low Density Lipoproteins Concentration
timeFrame: Four Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Faculté d'Odontologie, Université de Montpellier
name: Shahid A Shah, BDS, MPhil
role: PRINCIPAL_INVESTIGATOR
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