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IRCT20221016056199N1 IRCT 2022-12-11 Shiraz University of Medical Sciences The effect of Valsartan and Amlodipine combination with two different forms in controlling 24-hour ambulatory blood presure Comparison of the effect of Valsartan 80mg and Amlodipine 5mg as combination fix dose therapy and combination free drug therapy in controlling 24-hour ambulatory blood pressure 2022-12-22 anticipated 136 Complete https://irct.ir/trial/66367 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in this study was performed using permutation block randomization method (with block size=4). Patients will be assigned to each groups according to random list obtained by computer and randomization.com site. An assistant will include eligible patients to each groups (group A and B) according to random list and will divide Patients randomly into two groups of 68 using random list. The assistant is a different person from researchers and physicians involved in this study. Researchers and physicians are not aware of patients grouping and this allocation will not be evident to the conductors and study analyzers until the end of the study, Blinding description: Physicians, staff and those who analyze and evaluate the study results will not be aware of the patient grouping. To achieve blinding, patients will be divided into groups A and B with the mentioned randomization method but this allocation will not be evident to the conductors and study analyzers until the end of the study. Moreover, those who will collect holter data and those who will analyze and evaluate the data will not be aware of the patients grouping. 3 Essential Hypertension. Intervention 1: Intervention group 1: In this group, 68 patients randomly undergo 24-hour ambulatory blood pressure monitoring with blood pressure holter and then combination fix dose of Valsartan 80mg and amlodipine 5mg (single pill) (Valzomix from Abidi pharmaceutical company) will be used per oral daily for 2 months and after that patients undergo another 24-hour ambulatory blood pressure monitoring with blood pressure holter. The patients who were not known cases of hypertension and their high blood pressure were diagnosed in routine check ups will enter the study according to inclusion and exclusion criteria. Their 24-hour blood pressure will be measured by blood pressure holter and then fix dose combination of Valsartan 80mg and amlodipine 5mg once daily will be started for them. 72 hours later and also a month later patients will be asked and monitored whether any side effects has happened and whether they are consuming medication in a right way. After 2 months patients' 24-hour blood pressure will be measured again by blood pressure holter. Intervention 2: Intervention group 2: In this group, 68 patients randomly undergo 24-hour ambulatory blood pressure monitoring with blood pressure holter and then free drug combinations of Valsartan 80mg (Valsacor from Actoverco company) and amlodipine 5mg (Amlober from Actoverco company) (multi pill) will be used per oral daily for 2 months and after that patients undergo another 24-hour ambulatory blood pressure monitoring with blood pressure holter. The patients who were not known cases of hypertension and their high blood pressure were diagnosed in routine check ups will enter the study according to inclusion and exclusion criteria. Their 24-hour blood presuure will be measured by blood pressure holter and then free drug combination of Valsartan 80mg and amlodipine 5mg once daily will be started for them. 72 hours later and also a month later patients will be asked and monitored whether any side effects has happened and whether they are consuming medication in a right way. After 2 months patients' 24-hour blood pressure will be measured again by blood pressure holter. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to confidentiality of patients' information
public Kimia Falamarzi
No. 214, 8th Ave, Daneshgah blvd
Shiraz Iran (Islamic Republic of) 7194677476 +98 71 3646 3245 kimiafalamarzi@yahoo.com Shiraz University of Medical Sciences scientific Javad Kojuri
Cardiology department, Alzahra Heart Hospital, Sibooye Blvd
Shiraz Iran (Islamic Republic of) - +98 71 3735 5093 kojurij@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) New case of hypertension stage 1 or 2 hypertension 35 years 70 years Both Severe hypertension Secondary hypertension Positive history of ischemic heart disease Patients on anti-hypertensive drugs beforehand Patients who are not volunteered I10 Essential (primary) hypertension Treatment - Drugs Treatment - Drugs Intervention group 1: In this group, 68 patients randomly undergo 24-hour ambulatory blood pressure monitoring with blood pressure holter and then combination fix dose of Valsartan 80mg and amlodipine 5mg (single pill) (Valzomix from Abidi pharmaceutical company) will be used per oral daily for 2 months and after that patients undergo another 24-hour ambulatory blood pressure monitoring with blood pressure holter. The patients who were not known cases of hypertension and their high blood pressure were diagnosed in routine check ups will enter the study according to inclusion and exclusion criteria. Their 24-hour blood pressure will be measured by blood pressure holter and then fix dose combination of Valsartan 80mg and amlodipine 5mg once daily will be started for them. 72 hours later and also a month later patients will be asked and monitored whether any side effects has happened and whether they are consuming medication in a right way. After 2 months patients' 24-hour blood pressure will be measured again by blood pressure holter. Intervention group 2: In this group, 68 patients randomly undergo 24-hour ambulatory blood pressure monitoring with blood pressure holter and then free drug combinations of Valsartan 80mg (Valsacor from Actoverco company) and amlodipine 5mg (Amlober from Actoverco company) (multi pill) will be used per oral daily for 2 months and after that patients undergo another 24-hour ambulatory blood pressure monitoring with blood pressure holter. The patients who were not known cases of hypertension and their high blood pressure were diagnosed in routine check ups will enter the study according to inclusion and exclusion criteria. Their 24-hour blood presuure will be measured by blood pressure holter and then free drug combination of Valsartan 80mg and amlodipine 5mg once daily will be started for them. 72 hours later and also a month later patients will be asked and monitored whether any side effects has happened and whether they are consuming medication in a right way. After 2 months patients' 24-hour blood pressure will be measured again by blood pressure holter. Average 24-hour systolic and diastolic blood pressure. Timepoint: At the beginning of the study and 60 days after starting treatment. Method of measurement: Holter monitoring of blood pressure. Mean arterial pressure. Timepoint: At the beginning of the study and 60 days after starting treatment. Method of measurement: Holter monitoring of blood pressure. Average daytime systolic and diastolic blood pressure. Timepoint: At the beginning of the study and 60 days after starting treatment. Method of measurement: Holter monitoring of blood pressure. Average nighttime systolic and diastolic blood pressure. Timepoint: At the beginning of the study and 60 days after starting treatment. Method of measurement: Holter monitoring of blood pressure. Professor Kojuri heart clinic Approved 2021-12-21 Ethics committee of Shiraz University of Medical Sciences Shiraz university of medical sciences, school of medicine, Emam Hossein Square, Zand Blvd Shiraz Fars Iran (Islamic Republic of)