Observes a combined amlodipine and valsartan pill in newly diagnosed high blood pressure
Studies a combined amlodipine and valsartan pill in adults newly diagnosed with high blood pressure.
Key facts
- Who runs it
- The Searle Company Limited Pakistan
- Where
- Karachi and Peshawar, PakistanSee the 2 sites
- Trial code
- Registry title
- Clinical Response of EXTOR (Amlodipine/Valsartan) in Newly Diagnosed Hypertensive Patients.
- Status
- Recruiting
- People taking part
- 420 people, planned
- Started
- 28 Sept 2024
- Planned end
- 15 Sept 2025
- Type of study
- Observational
- Treatments tested
- Fixed-Dose Combination of Amlodipine/Valsartan
- Record updated
- 15 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 70 with newly found high blood pressure who have never taken blood pressure medicine.
- Age
- 18 to 70 years
- Sex
- Women and men can both join.
- Disease stage
- High blood pressure: systolic (top number) 140 mmHg or higher, or diastolic (bottom number) 90 mmHg or higher.
- Earlier treatment
- Must never have had treatment for high blood pressure.
Main reasons for not taking part
- Already taking blood pressure medicine
- High blood pressure caused by another illness (secondary hypertension)
- Pregnant women or nursing mothers
- Sudden (acute) illness or a psychiatric diagnosis
- Known allergy to the Extor product or its ingredients
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- • 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in Pakistan
- National Medical CentreKarachi, PakistanContact: Prof. Tariq Ashraf, MBBS, FCPS, FSCAI, FACCTaking people
- Kuwait Teaching HospitalPeshawar, PakistanContact: Abdur Rauf Prof, MBBS, FCPS, FACC, FESCTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Naive Hypertensive patients
Naive Pakistani subjects diagnosed as the case of Hypertension prescribed Extor in routine practice.
Treatment: Fixed-Dose Combination of Amlodipine/Valsartan
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Clinical Outcomes in Newly Diagnosed Hypertensive Patients With EXTOR (Fixed-Dose Combination of Amlodipine/Valsartan) in Routine Pakistani Practice.
- Plain-language title
- Observes a combined amlodipine and valsartan pill in newly diagnosed high blood pressureGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06625346, who can take part
- Record updated
- 15 May 2025