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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.
To assess the effectiveness of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients in 8 weeks.
Note: The safety is assessed in all subjects who received at least one dose of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naive Hypertensive patients | Naive Pakistani subjects diagnosed as the case of Hypertension prescribed Extor in routine practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed-Dose Combination of Amlodipine/Valsartan | Drug | Amlodipine and valsartan are two of the most commonly prescribed medications for the treatment of hypertension (high blood pressure). Amlodipine is a calcium channel blocker that works by relaxing the blood vessels, while valsartan is an angiotensin receptor blocker that works by blocking the effects of the hormone angiotensin II, which causes blood vessels to constrict. The combination of amlodipine and valsartan in a single pill has been shown to be more effective in lowering blood pressure than either medication alone. This is because the two medications have different mechanisms of action and work together to provide a more comprehensive approach to blood pressure control. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effectiveness of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients in 8 weeks. |
| 8 week |
| To assess the Health-Related Quality of Life of newly diagnosed hypertensive patients managed by Extor | • Change from Baseline to 4 week and 8 weeks in the Health-Related Quality of Life of newly diagnosed hypertensive patients managed by Extor, assess by Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9). For TSQM-9 questionnaire applies to assesses patient satisfaction with Extor medication including Effectiveness (3 items), Convenience (2 items), Side effects (2 items) and Global satisfaction (2 items). The TSQM-9 score from 01 to 07. The 01 score (minimum) is Extremely Dissatisfied and Score 07 (maximum) is Extremely Satisfied | 8 week |
| To assess the overall safety of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients. | Safety & tolerability will assess based on the incidence of reported TEAEs by system organ class ; preferred term, as well as by categories: TEAE, severe TEAE, serious TEAE, drug-related TEAE, drug-related severe TEAE, drug-related serious TEAE, TEAE leading to discontinuation, & TEAE with outcome of death. Drug-related TEAEs were defined as TEAEs assigned a Study Drug (Extor) relationship of adverse reaction & suspected adverse reaction. TEAEs were coded using the Medical Dictionary for Regulatory Activities, version 19.0. The severity of TEAEs are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. TEAEs were defined as any adverse event that started or increased in severity after the first dose of Study Drug on Day 1 through the Final Study Visit (8 weeks +/-3 days after last dose). |
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Inclusion Criteria:
Exclusion Criteria:
• Patients with already on antihypertensive treatment or secondary hypertension
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The subjects will be enrolled as per inclusion/exclusion criteria in the study. The total sample size of the study is 420 subjects with Hypertension for the multiple selected study sites and this will have 95% power to detect mean change from baseline to week 4-and 8 weeks for the evaluation of the effectiveness and overall safety response of Extorl for the Essential Hypertension treatment, assuming a standard deviation of the differences of 15.5, using 0.05 two-sided significance level considering 10% drop-out rate
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ALI Y Khanzada, MBBS, MSc | Contact | 922137170200 | 235 | ali.yasir@searlecompany.com |
| Ayesha Ashal, Doctor of Pharmacy | Contact | ayesha.ashal@searlecompany.com |
| Name | Affiliation | Role |
|---|---|---|
| Asif Mahmood, MBBS, MPH | The Searle Company Limited Pakistan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuwait Teaching Hospital | Recruiting | Peshawar | KPK | Pakistan |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| 8 week |
| National Medical Centre | Recruiting | Karachi | Pakistan |
|
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |