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Atorvastatin as an Antihypertensive Agent

Sponsor
Himayat Ullah (Other)
Overall Status
Completed
CT.gov ID
NCT05679102
Collaborator
Ayub Teaching Hospital (Other), Khyber Medical University Peshawar (Other)
120
Enrollment
1
Location
2
Arms
15
Actual Duration (Days)
243.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Amlodipine 5 MG Oral Tablet
  • Drug: Amlodipine 5 MG / Atorvastatin 10 MG Oral Tablet
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Atorvastatin in the Management of Hypertension
Actual Study Start Date :
Dec 20, 2022
Actual Primary Completion Date :
Jan 4, 2023
Actual Study Completion Date :
Jan 4, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Antihypertensive effect of atorvastatin [14 days]

    patients receiving atorvastatin based combination should have more decrease in the blood pressure.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shaqra University Shaqra Riyadh Saudi Arabia 15526

Sponsors and Collaborators

  • Himayat Ullah
  • Ayub Teaching Hospital
  • Khyber Medical University Peshawar

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Himayat Ullah, Assistant Professor, Shaqra University
ClinicalTrials.gov Identifier:
NCT05679102
Other Study ID Numbers:
  • DIR/KMU-EB/EA/000560
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 10, 2023
Last Verified:
Jan 1, 2023
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
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Amlodipine
Atorvastatin

Study Results

No Results Posted as of Jan 10, 2023