Essential HypertensionPhase 4NCT02058446
PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension
A Phase 4 study testing Amlodipine/Valsartan in people with Essential Hypertension, run by TSH Biopharm Corporation Limited at 1 site in Taiwan.
Trial summary
The antihypertensive effect of Amlodipine/Valsartan combination has been evaluated in worldwide populations including Asian patients. The study primarily aims to evaluate the effectiveness of Amlodipine/Valsartan combination in patients with essential hypertension in Taiwan using a prospective, open-label… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Amlodipine/Valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2013to Mar 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are 20-80 years of age
- Patients with essential hypertension (90 mmHg ≤ DBP ≤ 110 mmHg and/or 140 mmHg ≤ SBP ≤ 180 mmHg) whose BP is not adequately controlled with amlodipine (or another CCB) alone or with valsartan (or another ARB) alone, or with any antihypertensive monotherapy.
- Agree to and are able to follow the study procedures
- Understand the nature of the study, and have signed informed consent forms
Who cannot join
- Patients with any of the following conditions:
- Malignant (or history of malignant) hypertension
- Secondary hypertension
- Severe hypertension (mean sitting DBP ≥ 110 mmHg and/or mean sitting SBP ≥ 180 mmHg)
- A history of hypertensive encephalopathy or cerebrovascular accident
- Cerebrovascular accident, myocardial infraction within 3 months, or any type of revascularization
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- New York Heart Association class III -IV congestive heart failure
- Second- or third-degree heart block
- Angina pectoris
- Significant arrhythmia or valvular heart disease
- Significant pancreatic, hepatic, or renal disease
- Diabetes requiring insulin treatment or poorly controlled type 2 diabetes
- Patients with known contraindication or a history of allergy to CCBs or ARBs.
- Female patients who are pregnant or lactating.
- Male or female patients of child-bearing potential who do not agree to use an effective method of contraception during the study
- Patients is currently participating in any other clinical trial within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Postmarketing Study of Amlodipine/Valsartan Single-Pill Combination for the Treatment of Hypertension
The antihypertensive effect of Amlodipine/Valsartan combination has been evaluated in worldwide populations including Asian patients. The study primarily aims to evaluate the effectiveness of Amlodipine/Valsartan combination in patients with essential hypertension in Taiwan using a prospective, open-label, non-randomized approach.
The study also wants to investigate the safety of Amlodipine/Valsartan combination during the 6-week treatment period.
- Conditions
- Essential Hypertension
- Being tested
- Amlodipine/Valsartan
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine/ValsartanDrug
Also called Am-Daiwen®
Amlodipine/Valsartan: 5 mg/80 mg
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Amlodipine/Valsartan Single-Pill Combination Receives: Drug: Amlodipine/Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the change from baseline in office SBP measurements by cuff assessments at the end of the 6-week study period.
Measured: 6 weeks from baseline
Secondary outcomes (2)
To evaluate the change from baseline in office DBP measurements by cuff assessments after 6 weeks of treatment
Measured: 6 weeks from baseline
To evaluate the percentage of subjects who achieve BP goal as measured by cuff assessments (<140/90 mmHg) after 6 weeks of treatment
Measured: 6 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- TSH Biopharm Corporation Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kuo-Yang Wang, MD, PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058446
- Sponsor's protocol ID
- TSHAM1301
- Status last verified
- Feb 2014
- First submitted
- 4 Feb 2014
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Postmarketing Study of Amlodipine/Valsartan Single-Pill Combination for the Treatment of Hypertension
- ClinicalTrials.gov ID
- NCT02058446
- Acronym / sponsor ID
- TSHAM1301
- Conditions
- Essential Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- TSH Biopharm Corporation LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 Feb 2014 (estimated)
- 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 antihypertensive effect of Amlodipine/Valsartan combination has been evaluated in worldwide populations including Asian patients. The study primarily aims to evaluate the effectiveness of Amlodipine/Valsartan combination in patients with essential hypertension in Taiwan using a prospective, open-label, non-randomized approach.
The study also wants to investigate the safety of Amlodipine/Valsartan combination during the 6-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Amlodipine/ValsartanAmlodipine/Valsartan Single-Pill Combination |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are 20-80 years of age
- Patients with essential hypertension (90 mmHg ≤ DBP ≤ 110 mmHg and/or 140 mmHg ≤ SBP ≤ 180 mmHg) whose BP is not adequately controlled with amlodipine (or another CCB) alone or with valsartan (or another ARB) alone, or with any antihypertensive monotherapy.
- Agree to and are able to follow the study procedures
- Understand the nature of the study, and have signed informed consent forms
Key exclusion criteria (16 listed)
- Patients with any of the following conditions:
- Patients with known contraindication or a history of allergy to CCBs or ARBs.
- Female patients who are pregnant or lactating.
- Male or female patients of child-bearing potential who do not agree to use an effective method of contraception during the study
- Patients is currently participating in any other clinical trial within 30 days
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 |
|---|---|---|
| Amlodipine/ValsartanAlso: Am-Daiwen®Amlodipine/Valsartan: 5 mg/80 mg | Drug | Study group |
Primary outcome
To evaluate the change from baseline in office SBP measurements by cuff assessments at the end of the 6-week study period.
Time frame: 6 weeks from baseline
2 secondary outcomes
To evaluate the change from baseline in office DBP measurements by cuff assessments after 6 weeks of treatment
Time frame: 6 weeks from baseline
To evaluate the percentage of subjects who achieve BP goal as measured by cuff assessments (<140/90 mmHg) after 6 weeks of treatment
Time frame: 6 weeks from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
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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. This study is not recruiting at the moment.
Kuo-Yang Wang, MD, PhD principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amlodipine/Valsartan in people with Essential Hypertension, run by TSH Biopharm Corporation Limited at 1 site in Taiwan.
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 4 inclusion and 16 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: finished, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the change from baseline in office SBP measurements by cuff assessments at the end of the 6-week study period. (time frame: 6 weeks from baseline). 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 13 Nov 2015; AzTrials last refreshed its copy on 8 Nov 2026.