Atorvastatin Antihypertensive EffectNCT05679102
Atorvastatin as an Antihypertensive Agent
A study testing Amlodipine 5 MG Oral Tablet and Amlodipine 5 MG / Atorvastatin 10 MG Oral Tablet in people with Atorvastatin Antihypertensive Effect, run by Himayat Ullah at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Atorvastatin Antihypertensive Effect
- What is being tested?
- Amlodipine 5 MG Oral Tablet and Amlodipine 5 MG / Atorvastatin 10 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Dec 2022to 4 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria for the study were all newly diagnosed hypertensive patients aged 35 years and above with normal lipid profile
Who cannot join
- Patients with a history of dyslipidemias, diabetes mellites, chronic kidney disease, and ischemic heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Atorvastatin Antihypertensive Effect
- Being tested
- Amlodipine 5 MG Oral Tablet, Amlodipine 5 MG / Atorvastatin 10 MG Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine 5 MG Oral TabletDrug
one group will be given only Amlodipine 5MG once daily
Amlodipine 5 MG / Atorvastatin 10 MG Oral TabletDrug
one group will be given Amlodipine 5mg plus Atorvastatin 10MG once daily
| Study group | Role | What they receive |
|---|---|---|
| Amlopdipine only | Active comparator | Newly diagnosed hypertensive patients who will be given only amlodipine. Receives: Drug: Amlodipine 5 MG Oral Tablet |
| Amlodipine and Atorvastatin | Active comparator | Newly diagnosed hypertensive patients who will be given Amlodipine and Atorvastatin. Receives: Drug: Amlodipine 5 MG / Atorvastatin 10 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antihypertensive effect of atorvastatin
patients receiving atorvastatin based combination should have more decrease in the blood pressure.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start20 Dec 2022
- Primary completion4 Jan 2023
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atorvastatin Antihypertensive EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Himayat Ullah
- Sponsor type
- University, hospital or other
- Collaborators
- Ayub Teaching Hospital, Khyber Medical University Peshawar
- Responsible party
- Sponsor-investigator, Himayat Ullah, Shaqra University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679102
- Sponsor's protocol ID
- DIR/KMU-EB/EA/000560
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available to the principle researcher and corresponding researcher only.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atorvastatin in the Management of Hypertension
- ClinicalTrials.gov ID
- NCT05679102
- Acronym / sponsor ID
- DIR/KMU-EB/EA/000560
- Conditions
- Atorvastatin Antihypertensive Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Himayat UllahUniversity, hospital or other
- Collaborators
- Ayub Teaching Hospital, Khyber Medical University Peshawar
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amlopdipine only | Active comparator | Drug: Amlodipine 5 MG Oral TabletNewly diagnosed hypertensive patients who will be given only amlodipine. |
| Amlodipine and Atorvastatin | Active comparator | Drug: Amlodipine 5 MG / Atorvastatin 10 MG Oral TabletNewly diagnosed hypertensive patients who will be given Amlodipine and Atorvastatin. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria for the study were all newly diagnosed hypertensive patients aged 35 years and above with normal lipid profile
Key exclusion criteria (1 listed)
- Patients with a history of dyslipidemias, diabetes mellites, chronic kidney disease, and ischemic heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amlodipine 5 MG Oral Tabletone group will be given only Amlodipine 5MG once daily | Drug | Amlopdipine only |
| Amlodipine 5 MG / Atorvastatin 10 MG Oral Tabletone group will be given Amlodipine 5mg plus Atorvastatin 10MG once daily | Drug | Amlodipine and Atorvastatin |
Primary outcome
Antihypertensive effect of atorvastatin
Time frame: 14 days
patients receiving atorvastatin based combination should have more decrease in the blood pressure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Individual participant dataSharing planned: No. IPD will be available to the principle researcher and corresponding researcher only.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amlodipine 5 MG Oral Tablet and Amlodipine 5 MG / Atorvastatin 10 MG Oral Tablet in people with Atorvastatin Antihypertensive Effect, run by Himayat Ullah at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antihypertensive effect of atorvastatin (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.