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

Primary Purpose

Hypercholesterolemia, Hypertension, Cholesterol Deposition

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Amlodipine
Sponsored by
Ayub Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Hypercholesterolemia, Hypertension

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Newly Diagnosed Hypertensive patients

    Healthy Controls

    Arm Description

    These are the patients that have been clearly diagnosed with diabetes for the first time.

    Healthy Control Group

    Outcomes

    Primary Outcome Measures

    Measurement of Blood Glucose Concentration
    Measured as per protocols provided by the kit manufacturer.
    Measurement of Total Plasma Cholesterol Concentration
    Measured as per protocols provided by the kit manufacturer.
    Measurement of Plasma Triglyceride Concentration
    Measured as per protocols provided by the kit manufacturer.
    Measurement of Plasma High Density Lipoproteins Concentration
    Measured as per protocols provided by the kit manufacturer.
    Measurement of Plasma Low Density Lipoproteins Concentration
    Measured as per protocols provided by the kit manufacturer.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 16, 2021
    Last Updated
    July 18, 2022
    Sponsor
    Ayub Teaching Hospital
    Collaborators
    Khyber Medical University Peshawar
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05467384
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2016 (Actual)
    Primary Completion Date
    June 30, 2017 (Actual)
    Study Completion Date
    June 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ayub Teaching Hospital
    Collaborators
    Khyber Medical University Peshawar

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia, Hypertension, Cholesterol Deposition
    Keywords
    Hypercholesterolemia, Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Case with healthy control
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Newly Diagnosed Hypertensive patients
    Arm Type
    Experimental
    Arm Description
    These are the patients that have been clearly diagnosed with diabetes for the first time.
    Arm Title
    Healthy Controls
    Arm Type
    No Intervention
    Arm Description
    Healthy Control Group
    Intervention Type
    Drug
    Intervention Name(s)
    Amlodipine
    Other Intervention Name(s)
    Norvasc
    Intervention Description
    5mg/day in two divided doses
    Primary Outcome Measure Information:
    Title
    Measurement of Blood Glucose Concentration
    Description
    Measured as per protocols provided by the kit manufacturer.
    Time Frame
    Four Months
    Title
    Measurement of Total Plasma Cholesterol Concentration
    Description
    Measured as per protocols provided by the kit manufacturer.
    Time Frame
    Four Months
    Title
    Measurement of Plasma Triglyceride Concentration
    Description
    Measured as per protocols provided by the kit manufacturer.
    Time Frame
    Four Months
    Title
    Measurement of Plasma High Density Lipoproteins Concentration
    Description
    Measured as per protocols provided by the kit manufacturer.
    Time Frame
    Four Months
    Title
    Measurement of Plasma Low Density Lipoproteins Concentration
    Description
    Measured as per protocols provided by the kit manufacturer.
    Time Frame
    Four Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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 Normal lipid profile. Normotensive (BP < 140/90mmHg). Exclusion criteria for controls 1) Any major illness.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shahid A Shah, BDS, MPhil
    Organizational Affiliation
    Faculté d'Odontologie, Université de Montpellier
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Effect of Amlodipine on the Lipid Profile of Newly Diagnosed Hypertensive Patients

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