Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:12 AM
Study NCT ID:
NCT07389304
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-05
First Post:
2026-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
[Effects of Selected Statins on Cardiovascular Parameters in Healthy Volunteers]
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The PI will give the assigned medication to each participant according to randomization and allocation. All the personnel involved in the study will be kept blind.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The selected statins i.e Simvastatin (5mg, 20mg, 40mg), atorvastatin (10mg,20mg, 40mg) and simvastatin(10mg, 20mg, 40mg) will be given orally to the participants of different assigned randomized participants groups in once daily dosing for two days to assess the effect on blood pressure and ECG.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-30', 'studyFirstSubmitDate': '2026-01-20', 'studyFirstSubmitQcDate': '2026-01-30', 'lastUpdatePostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure Measurements', 'timeFrame': 'before dosing and 2 days after dosing achieving peak plasma concentrations respectively]', 'description': 'Blood Pressure of the subjects will be determined by sphygmomanometer'}], 'secondaryOutcomes': [{'measure': 'Electrocardiograms (ECGs) Measurements', 'timeFrame': 'before dosing and 2 days after dosing achieving peak plasma concentrations respectively]', 'description': 'ECGs of the subjects will be determined by 12 Leads ECG Machine.QT interval and QRS complex in milliseconds will be analyzed to determine the effects of these statins on ECG morphology'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sBlood Pressure,ECG change'], 'conditions': ['Lipid Profile,Blood Pressure']}, 'descriptionModule': {'briefSummary': 'This study is a Phase I randomized clinical trial aiming to investigate the short-term effects of three commonly prescribed statins i.e (Atorvastatin, Rosuvastatin, and Simvastatin) at different dose levels i.e lo,median and high doses on cardiovascular parameters i.e Blood pressure and ECG morphology in healthy volunteers. The study will assess changes in blood pressure and ECG morphology following two days of statin administration under controlled conditions.', 'detailedDescription': 'The goal of this study is to evaluate the effects of these three statins on the cardiovascular parameters in a dose-dependent manner. In this Phase 1 clinical trial we will enroll healthy volunteers who will be randomized to receive one of three statins at low, moderate, or high doses for two days. .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n* Normal ECG\n* Normal Blood Pressure\n* Normal lipid levels\n\nExclusion Criteria:\n\n* Participants with a history of diabetes mellitus,BP\n* With chronic diseases e.g heart disease, kidney disease\n* QTc ≥450 ms (men) or ≥470 ms (women)\n* ECG changes\n* Electrolyte imbalance,\n* Participants taking other medications'}, 'identificationModule': {'nctId': 'NCT07389304', 'acronym': 'SBBU/IRC-25-31', 'briefTitle': '[Effects of Selected Statins on Cardiovascular Parameters in Healthy Volunteers]', 'organization': {'class': 'OTHER', 'fullName': 'Shaheed Benazir Bhutto University Sheringal Dir Upper'}, 'officialTitle': '[EFFECTS OF SELECTED STATINS ON CARDIOVASCULAR PARAMETERS IN HEALTHY VOLUNTEERS: A RANDAMOZIED PHASE I CLINICAL TRIAL]', 'orgStudyIdInfo': {'id': '[SBBU/PHM-25-32]'}, 'secondaryIdInfos': [{'id': 'SBBU/IREC-25-32]', 'type': 'OTHER', 'domain': '[ShaheedBenazirBhuttoUSheringalDU]'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rosuvastatin (5mg, 20mg, 40mg)', 'description': 'The assigned participants will be given Rosuvastatin 5mg, 20mg, 40mg OD for two days', 'interventionNames': ['Drug: Rosuvastatin (5mg, 20mg, 40mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Atorvastatin (10mg,20mg, 40mg)', 'description': 'The assigned participants will be given Atorvastatin 10mg,20mg, 40mg OD for two days', 'interventionNames': ['Drug: Atorvastatin (10mg, 20mg, 40mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Simvastatin (10mg, 20mg, 40mg)', 'description': 'The assigned participants will be given Simvastatin 10mg, 20mg, 40mg OD for two days', 'interventionNames': ['Drug: Simvastatin (10mg, 20mg, 40m']}], 'interventions': [{'name': 'Rosuvastatin (5mg, 20mg, 40mg)', 'type': 'DRUG', 'description': 'The Rosuvastatin (5mg, 20mg, 40mg) group participants will be given the drug orally OD for two days', 'armGroupLabels': ['Rosuvastatin (5mg, 20mg, 40mg)']}, {'name': 'Atorvastatin (10mg, 20mg, 40mg)', 'type': 'DRUG', 'description': 'The Atorvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days', 'armGroupLabels': ['Atorvastatin (10mg,20mg, 40mg)']}, {'name': 'Simvastatin (10mg, 20mg, 40m', 'type': 'DRUG', 'description': 'The Simvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days', 'armGroupLabels': ['Simvastatin (10mg, 20mg, 40mg)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dīr', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'contacts': [{'name': 'Dr.Abid Ullah, PhD', 'role': 'CONTACT', 'email': 'abid@sbbu.edu.pk', 'phone': '0944885400'}, {'name': 'Professor Dr. Niaz Ali, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Shaheed Benazir Bhutto University Sheringal Dir Upper', 'geoPoint': {'lat': 35.2074, 'lon': 71.8768}}], 'centralContacts': [{'name': 'Dr Abid Ullah, Ph.D', 'role': 'CONTACT', 'email': 'abid@sbbu.edu.pk', 'phone': '09448850', 'phoneExt': '527'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'ipdSharing': 'YES', 'description': 'The study results will be shared in well reputable Journals without the participant identifiers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaheed Benazir Bhutto University Sheringal Dir Upper', 'class': 'OTHER'}, 'collaborators': [{'name': 'Khyber Medical University Peshawar', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Dr Abid Ullah', 'investigatorAffiliation': 'Shaheed Benazir Bhutto University Sheringal Dir Upper'}}}}