HypertensionHELPNCT06625346
Clinical Response of EXTOR (Amlodipine/Valsartan) in Newly Diagnosed Hypertensive Patients.
An observational study of Hypertension, run by The Searle Company Limited Pakistan at 2 sites in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Fixed-Dose Combination of Amlodipine/Valsartan
- Type of treatment
- Pill or oral medicine
- How many people
- 420 participants
- Where
- 2 sitesPakistan
- Study dates
- 28 Sep 2024to 15 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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 join
- • 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ayesha Ashal, Doctor of Pharmacy contact
Pakistan2 sites, 2 recruiting
- Recruiting
National Medical Centre
Karachi
Prof. Tariq Ashraf, MBBS, FCPS, FSCAI, FACC, 922135845475, tariqk313@gmail.com
- Recruiting
Kuwait Teaching Hospital
Peshawar, KPK
Abdur Rauf Prof, MBBS, FCPS, FACC, FESC
About this study
Official title: Clinical Outcomes in Newly Diagnosed Hypertensive Patients With EXTOR (Fixed-Dose Combination of Amlodipine/Valsartan) in Routine Pakistani Practice.
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.
Read the detailed description
To assess the effectiveness of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients in 8 weeks.
- Change from Baseline to 8 weeks in Systolic Blood Pressure (SBP) From standard Blood Pressure Measurement.
- Change from Baseline to 8 weeks in Diastolic Blood Pressure (DBP) From standard Blood Pressure Measurement.
- Change from Baseline to 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)
- Change from baseline to 4 weeks in Diastolic Blood Pressure (SBP) From standard Blood Pressure Measurement
- Change from baseline to 4 weeks in Diastolic Blood Pressure (DBP) From standard Blood Pressure Measurement
- Change from baseline to 4 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)
- To assess the overall safety of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients.
Note: The safety is assessed in all subjects who received at least one dose of study drug.
- Conditions
- Hypertension
- Being tested
- Fixed-Dose Combination of Amlodipine/Valsartan
- Keywords
- Hypertnsion, Amlodipine valsartan combination, Quality of life (QoL), Pakistan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed-Dose Combination of Amlodipine/ValsartanDrug
Also called EXTOR
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.
| Study group | Role | What they receive |
|---|---|---|
| Naive Hypertensive patients | Naive Pakistani subjects diagnosed as the case of Hypertension prescribed Extor in routine practice. Receives: Drug: Fixed-Dose Combination of Amlodipine/Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effectiveness of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients in 8 weeks.
- Change from Baseline to 4 week and 8 weeks in Systolic Blood Pressure (SBP) From standard Blood Pressure Measurement. The achieve BP control defined as systolic BP less than 140 mmHg at any of their clinic visits and maintained at the 8 week of treatment clinic visit.
- Change from Baseline to 4 week and 8 weeks in Diastolic Blood Pressure (DBP) From standard Blood Pressure Measurement. The achieve BP control defined as Diastolic BP less than 90 mmHg at any of their clinic visits and maintained at the 8 week of treatment clinic visit.
Measured: 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
Measured: 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).
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start28 Sep 2024
- Primary completion30 Aug 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Searle Company Limited Pakistan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Asif Mahmood, MBBS, MPH, Study director, The Searle Company Limited Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625346
- Sponsor's protocol ID
- TSCL-HELP-01
- Acronym
- HELP
- Status last verified
- May 2025
- First submitted
- 19 Mar 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes in Newly Diagnosed Hypertensive Patients With EXTOR (Fixed-Dose Combination of Amlodipine/Valsartan) in Routine Pakistani Practice.
- ClinicalTrials.gov ID
- NCT06625346
- Acronym / sponsor ID
- HELP / TSCL-HELP-01
- Conditions
- Hypertension
- Keywords
- Hypertnsion, Amlodipine valsartan combination, Quality of life (QoL), Pakistan
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- The Searle Company Limited PakistanIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2024 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To assess the effectiveness of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients in 8 weeks.
- Change from Baseline to 8 weeks in Systolic Blood Pressure (SBP) From standard Blood Pressure Measurement.
- Change from Baseline to 8 weeks in Diastolic Blood Pressure (DBP) From standard Blood Pressure Measurement.
- Change from Baseline to 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)
- Change from baseline to 4 weeks in Diastolic Blood Pressure (SBP) From standard Blood Pressure Measurement
- Change from baseline to 4 weeks in Diastolic Blood Pressure (DBP) From standard Blood Pressure Measurement
- Change from baseline to 4 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)
- To assess the overall safety of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients.
Note: The safety is assessed in all subjects who received at least one dose of study drug.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Naive Hypertensive patients | – | Drug: Fixed-Dose Combination of Amlodipine/ValsartanNaive Pakistani subjects diagnosed as the case of Hypertension prescribed Extor in routine practice. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- • Patients with already on antihypertensive treatment or secondary hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed-Dose Combination of Amlodipine/ValsartanAlso: EXTORAmlodipine 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. | Drug | Naive Hypertensive patients |
Primary outcome
To assess the effectiveness of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients in 8 weeks.
Time frame: 8 week
* Change from Baseline to 4 week and 8 weeks in Systolic Blood Pressure (SBP) From standard Blood Pressure Measurement. The achieve BP control defined as systolic BP less than 140 mmHg at any of their clinic visits and maintained at the 8 week of treatment clinic visit. * Change from Baseline to 4 week and 8 weeks in Diastolic Blood Pressure (DBP) From standard Blood Pressure Measurement. The achieve BP control defined as Diastolic BP less than 90 mmHg at any of their clinic visits and maintained at the 8 week of treatment clinic visit.
To assess the Health-Related Quality of Life of newly diagnosed hypertensive patients managed by Extor
Time frame: 8 week
• 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
To assess the overall safety of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients.
Time frame: 8 week
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayesha Ashal, Doctor of Pharmacy contact
Asif Mahmood, MBBS, MPH study director
The Searle Company Limited Pakistan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by The Searle Company Limited Pakistan at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ALI Y Khanzada, MBBS, MSc (922137170200 ext. 235, ali.yasir@searlecompany.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effectiveness of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients in 8 weeks. (time frame: 8 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.