Atorvastatin as an Antihypertensive Agent

NCT05679102 | Completed DMC

• 1 other identifier: DIR/KMU-EB/EA/000560
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Atorvastatin Antihypertensive Effect

Outcome Measures

Primary Outcomes (1)

• Antihypertensive effect of atorvastatin

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

  14 days

Study Arms (2)

Amlopdipine only

ACTIVE COMPARATOR

Newly diagnosed hypertensive patients who will be given only amlodipine.

Drug: Amlodipine 5 MG Oral Tablet

Amlodipine and Atorvastatin

ACTIVE COMPARATOR

Newly diagnosed hypertensive patients who will be given Amlodipine and Atorvastatin.

Drug: Amlodipine 5 MG / Atorvastatin 10 MG Oral Tablet

Interventions

Amlodipine 5 MG Oral Tablet DRUG

one group will be given only Amlodipine 5MG once daily

Amlopdipine only

Amlodipine 5 MG / Atorvastatin 10 MG Oral Tablet DRUG

one group will be given Amlodipine 5mg plus Atorvastatin 10MG once daily

Amlodipine and Atorvastatin

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Himayat Ullah: lead
• Ayub Teaching Hospital: collaborator
• Khyber Medical University Peshawar: collaborator

Study Sites (1)

Shaqra University

Shaqra, Riyadh Region, 15526, Saudi Arabia

Location

MeSH Terms

Interventions

Amlodipine; Tablets; Atorvastatin

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 10, 2023
• Study Start: December 20, 2022
• Primary Completion: January 4, 2023
• Study Completion: January 4, 2023
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)