Comparison of morning vs. evening administration of Amlodipine/Valsartan in hypertensive patients at Loghman hospital

The purpose of study is to investigate the effect of the time of administration (morning and evening) of Amilodipine/Valsartan on hypertension control. Often, hypertension cannot be properly controlled with a single drug, and few studies have yet investigated the different effects of combination therapy depending on timing of administration.

The clinical trial is performed with two parallel intervention groups (morning with evening), double blinded, randomized through simple randomization by card shuffling, and study phase of 2-3 on 100 patients.

After obtaining informed consent, 100 patients with second-stage hypertension according to the guidelines of the American Heart Association (AHA2017/ACC) were randomly assigned to two groups in the morning and evening. And during a randomized trial, they are treated with the combination drug Valsartan (160 mg per day)/Amlodipine (5 mg per day) for 8 weeks.

Inclusion criteria: 1. Age between 35-75 2. No underlying disease 3. No previous hypertension treatment 4. Consent to enter the study ;Exclusion criteria: 1. Having renal diseases 2. Having diabetes Mellitus 3. Having cardiovascular diseases including ischemic, non-ischemic, and heart failure

Intervention group 1 (morning): Due to inclusion criteria, patients with hypertension stage II (according to ACCAHA2017) who indicated, take Amilodipine/Valsartan in the morning. Intervention group 2 (evening): Due to inclusion criteria, patients with hypertension stage II (according to ACCAHA2017) who indicated, take Amilodipine/Valsartan in the evening. Relying on ethics of treating all patients with second-stage hypertension, this study does not include a control group.

Blood pressure control after 8 weeks (comparison of blood pressure before and after the intervention) Side effects of the drug

Create a random sequence as simple randomization by the "Card Shuffling" method. So, 50 cards will be the first group (morning) and the other 50 cards for the second group (evening). Then, by shuffling, a card is selected and its allocation is documented, then the card is returned to the other cards. Also, the cards are shuffled again and another card is selected. This process will continue until reaching a random sequence according to the sample size (100). Allocation concealment will be done by placing the cards inside Sequentially Numbered Sealed Opaque Envelopes (SNOSE). Research team who are responsible for the above steps will not enter other steps of the research, especially assessment of patients in terms of the dependent variables.

All researchers related to each separate step of the study, including randomization, data collection, assessment of drug side effects, and finally analysis of the data, will not participate in other steps. As a example, researchers who measure and document blood pressure of patients do not know whether the patient is in the morning or the evening group, preventing the bias of blood pressure measurement. Also, researchers who are responsible for randomly assigning patients to the morning or evening group will not participate in the next steps, including data analyzing of patients, measuring blood pressure or assessing drug side effects. Patients are classified into intervention groups with general knowledge of the study groups and with informed consent.

All data is potentially shareable after de-identifying individuals

The access period starts 2 months after the results are published

Researchers working in academic institutions

For the purpose of wider analysis with the discretion of the expert professors related to the research

To Dr. Marjan Hadian marjan7437@gmail.com Makhsus St ,Qazvin St ,Tehran ,Iran 00982155419005 Postal code: 133635445

By sending an e-mail request to the responsible professor and discussing in the Research Council of Loqman Hospital, your request will be answered within a maximum of 2 weeks.