Clincosm LogoSign in Get a demo

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

Sponsor
Ayub Teaching Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05467384
Collaborator
Khyber Medical University Peshawar (Other)
80
Enrollment
2
Arms
16
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Case with healthy controlCase with healthy control
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Effect of Amlodipine on the Lipid Profile of Newly Diagnosed Hypertensive Patients
Actual Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Jun 30, 2017
Actual Study Completion Date :
Jun 30, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Newly Diagnosed Hypertensive patients

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

Drug: Amlodipine
5mg/day in two divided doses
Other Names:
  • Norvasc

    		•
    No Intervention: Healthy Controls

    Healthy Control Group

    Outcome Measures

    Primary Outcome Measures

    1. Measurement of Blood Glucose Concentration [Four Months]

      Measured as per protocols provided by the kit manufacturer.

    2. Measurement of Total Plasma Cholesterol Concentration [Four Months]

      Measured as per protocols provided by the kit manufacturer.

    3. Measurement of Plasma Triglyceride Concentration [Four Months]

      Measured as per protocols provided by the kit manufacturer.

    4. Measurement of Plasma High Density Lipoproteins Concentration [Four Months]

      Measured as per protocols provided by the kit manufacturer.

    5. Measurement of Plasma Low Density Lipoproteins Concentration [Four Months]

      Measured as per protocols provided by the kit manufacturer.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    2. 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ayub Teaching Hospital
    • Khyber Medical University Peshawar

    Investigators

    • Principal Investigator: Shahid A Shah, BDS, MPhil, Faculté d'Odontologie, Université de Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Shahid ali shah, Assistant Professor, Ayub Teaching Hospital
    ClinicalTrials.gov Identifier:
    NCT05467384
    Other Study ID Numbers:
    • sashah0002
    First Posted:
    Jul 20, 2022
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shahid ali shah, Assistant Professor, Ayub Teaching Hospital
    Hypercholesterolemia
    Hypertension
    Additional relevant MeSH terms:
    Hypertension
    Hypercholesterolemia
    Amlodipine

    Study Results

    No Results Posted as of Jul 20, 2022