Atorvastatin as an Antihypertensive Agent

January 9, 2023 updated by: Himayat Ullah

Effect of Atorvastatin in the Management of Hypertension

This study is aimed to see the antihypertensive effect of statin (Atorvastatin) as certain animal models have shown that statins have the voltage-gated calcium channel blocking effect. It will be a randomized controlled trial that will be done in Ayub Hospital Complex Abbottabad. After ethical approval, 120 patients with newly diagnosed hypertension belonging to either gender and aged 35 and above will be enrolled in the trial. They will randomly be grouped into two groups with each group comprising 60 patients. One group will be administered Amlodipine 5 mg PO once a day, while the other one will be given 5mg Amlodipine plus 10 mg Atorvastatin. The patients will be examined on a follow-up visit 14 days later and blood pressure will be recorded as per protocols.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Riyadh
      • Shaqra, Riyadh, Saudi Arabia, 15526
        • Shaqra University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- The inclusion criteria for the study were all newly diagnosed hypertensive patients aged 35 years and above with normal lipid profile

Exclusion Criteria:

  • Patients with a history of dyslipidemias, diabetes mellites, chronic kidney disease, and ischemic heart disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Amlopdipine only
Newly diagnosed hypertensive patients who will be given only amlodipine.
Drug: Amlodipine 5 MG Oral Tablet
one group will be given only Amlodipine 5MG once daily
Active Comparator: Amlodipine and Atorvastatin
Newly diagnosed hypertensive patients who will be given Amlodipine and Atorvastatin.
Drug: Amlodipine 5 MG / Atorvastatin 10 MG Oral Tablet
one group will be given Amlodipine 5mg plus Atorvastatin 10MG once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antihypertensive effect of atorvastatin
Time Frame: 14 days
patients receiving atorvastatin based combination should have more decrease in the blood pressure.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Himayat Ullah

Collaborators

Khyber Medical University Peshawar
Ayub Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2022

Primary Completion (Actual)

January 4, 2023

Study Completion (Actual)

January 4, 2023

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Estimate)

January 10, 2023

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIR/KMU-EB/EA/000560

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD will be available to the principle researcher and corresponding researcher only.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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