NCT06625346Recruiting
Clinical Response of EXTOR (Amlodipine/Valsartan) in Newly Diagnosed Hypertensive Patients.
Clinical Outcomes in Newly Diagnosed Hypertensive Patients With EXTOR (Fixed-Dose Combination of Amlodipine/Valsartan) in Routine Pakistani Practice.
Source: ClinicalTrials.gov · Last updated 15 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The American College of Cardiology/American Heart Association hypertension guidelines recommend treatment initiation with dual antihypertensive therapy in adults with stage 2 hypertension (corresponding to grade 1 and 2 in the ESH classification) and an average BP \>20/10 mm Hg above target. Amlodipine and valsartan are two of the most commonly prescribed medications for the treatment of hypertension (high blood pressure). In Pakistan multiple studies were conducted on Hypertension and use of Single Pill Combination in uncontrolled Hypertension. However, no study was conducted to assess the role of Single Pill Combination (SPC) like Amlodipine and Valsartan in newly diagnosed hypertension and to assess their quality of life by patients' satisfaction with their medication after managing the hypertension with the SPC.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 420 (estimated)
- First submitted
- 19 Mar 2024
- Start date
- 28 Sept 2024
- Primary completion date
- 30 Aug 2025
- Lead sponsor
- The Searle Company Limited Pakistan
- Diseases
- High blood pressure
- NCT number
- NCT06625346
What you commit to
- Study type: Observational
- Planned participants: 420
- From 28 Sept 2024 to the primary completion date, 30 Aug 2025
- 2 sites 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 with already on antihypertensive treatment or secondary hypertension
- Pregnant women or nursing mothers
- Patients with acute illnesses or psychiatric diagnosis
- Known hypersensitivity to Extor product, the metabolites, or formulation excipients.
- Treated with Extor to evaluate safety as per approved prescribing information for Extor in Pakistan.
Who the study is looking for
- Patient with a clinical history of Hypertension (systolic blood pressure greater than or equal to 140 mmHg or a diastolic blood pressure greater than or equal to 90 mmHg) and never had antihypertensive treatment.
- Patient aged ≥18 and ≤70 years inclusive of either sex.
- Patient with ability to understand and sign written informed consent form.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Medical Centre Coordinator of this site? Confirm its status | Karachi | Pakistan | Recruiting |
| Kuwait Teaching Hospital Coordinator of this site? Confirm its status | Peshawar | Pakistan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.