Atorvastatin as an Antihypertensive Agent | NCT05679102

Studies
Atorvastatin as an Antihypertensive Agent

NCT05679102

Sponsor

Himayat Ullah

Status

Completed

Last Update Posted

Jan 10, 2023Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Atorvastatin Antihypertensive Effect

Interventions

Amlodipine 5 MG Oral Tablet
Amlodipine 5 MG / Atorvastatin 10 MG Oral Tablet

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2022Actual

Primary Completion Date

Jan 4, 2023Actual

Completion Date

Jan 4, 2023Actual

First Submitted Date

Jan 9, 2023

First Submission Date that Met QC Criteria

Jan 9, 2023

First Posted Date

Jan 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2023

Last Update Posted Date

Jan 10, 2023Actual

Name	Class
Ayub Teaching Hospital	OTHER
Khyber Medical University Peshawar	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Amlodipine 5 MG Oral Tablet	Drug	one group will be given only Amlodipine 5MG once daily	Amlopdipine only

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shaqra University		Shaqra	Riyadh Region	15526	Saudi Arabia

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017311	Amlodipine
D013607	Tablets
D000069059	Atorvastatin

Ancestor Terms

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

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Browse Branches

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