NCT06487949CompletedPhase 4
Valsartan and Amlodipine in Blood Pressure Management: Fixed-Dose vs. Free Drug Therapy
Comparative Analysis of Valsartan 80 mg and Amlodipine 5 mg in Fixed-Dose Combination Therapy Versus Combination Free Drug Therapy for Ambulatory Blood Pressure Management: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 5 Jul 2024
Brief summary (registry, in English)
Patients aged 35 to 70 years with newly diagnosed stage 1 or 2 hypertension ( HTN) was randomized to receive either Valsartan 80 mg/Amlodipine 5 mg fix dose combination (FDC) or a free equivalent combination. Ambulatory blood pressure monitoring at baseline and 8 weeks post-treatment initiation was performed.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 114 (actual)
- First submitted
- 28 Jun 2024
- Start date
- 1 Dec 2022
- Primary completion date
- 1 Oct 2023
- Lead sponsor
- Shiraz University of Medical Sciences
- Diseases
- High blood pressure
- NCT number
- NCT06487949
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 114
- From 1 Dec 2022 to the primary completion date, 1 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients previously been on antihypertensive drugs
Other illness
- Patients had ischemic heart disease in the past
Other
- Patients had secondary high blood pressure
- Patients had severe high blood pressure (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 110 mmHg)
- Patients were unable to receive any part of the treatment
- Patients who refuse to take part in study
Who the study is looking for
- Patients diagnosed with stage 1 or 2 hypertension at the time of enrollment, according to the 2017 ACC/AHA Guidelines (systolic blood pressure \> 130 mmHg and/or diastolic blood pressure \> 80 mmHg), and required the initiation of antihypertensive medications
Age in the registry: 35 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shiraz University of Medical Sciences Coordinator of this site? Confirm its status | Shiraz | Iran | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.