Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-02-21 @ 4:08 AM
Study NCT ID:
NCT05679102
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2023-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atorvastatin as an Antihypertensive Agent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-09', 'studyFirstSubmitDate': '2023-01-09', 'studyFirstSubmitQcDate': '2023-01-09', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antihypertensive effect of atorvastatin', 'timeFrame': '14 days', 'description': 'patients receiving atorvastatin based combination should have more decrease in the blood pressure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atorvastatin Antihypertensive Effect']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- The inclusion criteria for the study were all newly diagnosed hypertensive patients aged 35 years and above with normal lipid profile\n\nExclusion Criteria:\n\n* Patients with a history of dyslipidemias, diabetes mellites, chronic kidney disease, and ischemic heart disease'}, 'identificationModule': {'nctId': 'NCT05679102', 'briefTitle': 'Atorvastatin as an Antihypertensive Agent', 'organization': {'class': 'OTHER', 'fullName': 'Shaqra University'}, 'officialTitle': 'Effect of Atorvastatin in the Management of Hypertension', 'orgStudyIdInfo': {'id': 'DIR/KMU-EB/EA/000560'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Amlopdipine only', 'description': 'Newly diagnosed hypertensive patients who will be given only amlodipine.', 'interventionNames': ['Drug: Amlodipine 5 MG Oral Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amlodipine and Atorvastatin', 'description': 'Newly diagnosed hypertensive patients who will be given Amlodipine and Atorvastatin.', 'interventionNames': ['Drug: Amlodipine 5 MG / Atorvastatin 10 MG Oral Tablet']}], 'interventions': [{'name': 'Amlodipine 5 MG Oral Tablet', 'type': 'DRUG', 'description': 'one group will be given only Amlodipine 5MG once daily', 'armGroupLabels': ['Amlopdipine only']}, {'name': 'Amlodipine 5 MG / Atorvastatin 10 MG Oral Tablet', 'type': 'DRUG', 'description': 'one group will be given Amlodipine 5mg plus Atorvastatin 10MG once daily', 'armGroupLabels': ['Amlodipine and Atorvastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15526', 'city': 'Shaqra', 'state': 'Riyadh Region', 'country': 'Saudi Arabia', 'facility': 'Shaqra University', 'geoPoint': {'lat': 25.24019, 'lon': 45.25104}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will be available to the principle researcher and corresponding researcher only.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Himayat Ullah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ayub Teaching Hospital', 'class': 'OTHER'}, {'name': 'Khyber Medical University Peshawar', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Himayat Ullah', 'investigatorAffiliation': 'Shaqra University'}}}}