Effect of Amlodipine and Valsartan on newly diagnosed hypertension
Clinical Outcomes in Newly Diagnosed Hypertensive Patients With EXTOR (Fixed-Dose Combination of Amlodipine/Valsartan) in Routine Pakistani Practice.
This study tests if a combination of Amlodipine and Valsartan can help people who have just been diagnosed with high blood pressure feel better and improve their quality of life over eight weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 420 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The Searle Company Limited Pakistan Industry-sponsored |
| Locations | 2 sites (Peshawar, KPK and 1 other locations) |
| Trial ID | NCT06625346 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of a fixed-dose combination of Amlodipine and Valsartan (EXTOR) in patients newly diagnosed with hypertension over an 8-week period. It aims to measure changes in systolic and diastolic blood pressure, as well as assess the health-related quality of life and patient satisfaction with the medication using the Treatment Satisfaction Questionnaire for Medication (TSQM-9). The study will also monitor the overall safety of the EXTOR treatment in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 who have been newly diagnosed with hypertension and have not previously received antihypertensive treatment.
Not a fit: Patients who are already on antihypertensive treatment or have secondary hypertension will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for newly diagnosed hypertensive patients, improving their blood pressure control and quality of life.
How similar studies have performed: While multiple studies have explored hypertension treatments, this specific approach using a single pill combination in newly diagnosed patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * • 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.
Where this trial is running
Peshawar, KPK and 1 other locations
- Kuwait Teaching Hospital — Peshawar, Kpk, Pakistan (Recruiting)
- National Medical Centre — Karachi, Pakistan (Recruiting)
Study contacts
- Study coordinator: ALI Y Khanzada, MBBS, MSc
- Email: ali.yasir@searlecompany.com
- Phone: 922137170200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.