HypertensionPhase 4NCT01541189
Double-dose Valsartan Monotherapy in Hypertension Treatment: an Effectiveness and Safety Evaluation in Chinese Patients.
A Phase 4 study testing Valsartan in people with Hypertension, run by Novartis Pharmaceuticals at 1 site in China.
Trial summary
To evaluate efficacy and safety of valsartan 160mg in Chinese hypertensive patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Valsartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Jan 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Naive primary hypertension patients or primary hypertensive patients on mono antihypertensive therapy:
- All treatment-naive patients need to have 140mmHg≤MSSBP<180mmHg and 90mmHg≤MSDBP< 110mmHg at visit 1
- For patients on mono antihypertensive therapy, MSSBP/MSDBP should <160/100mmHg at visit 1 (the beginning of screening period); and at visit 2(the beginning of theraputic period), they should have MSSBP≥140 mmHg and <180mmHg AND MSDBP≥90 mmHg and <110mmHg
Who cannot join
- Severe hypertension
- Malignant hypertension
- Secondary hypertension
- Renal dysfunction(serum creatinine > 2.0mg(176.8μmol/L)at visit 1)
- Hepatic disease
- History of hypertensive encephalopathy or cerebrovascular accident within 6 months
Show all 13Show fewer
- History of myocardial infarction, coronary revascularization within 6 months
- Type 1 diabetes mellitus
- patietns with HbA1c >8% at visit 1
- Women in pregnancy and lactation
- Potentially fertile female patients not using effective contraceptive methods
- Be allergy to study drug.
- Other protocol defined inclusion/exlusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 8-week, Multi Center(10),Single Arm, Open-labeled Prospective Study of Valsartan 160 mg in 200 Mild to Moderate Chinese Hypertension Patients Forced Titrated From 2-week Therapy of Valsartan 80 mg.
To evaluate efficacy and safety of valsartan 160mg in Chinese hypertensive patients.
- Conditions
- Hypertension
- Being tested
- Valsartan
- Keywords
- hypertension, valsartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValsartanDrug
80 mg/day for 2 weeks, up-titrated to 160 mg/day for further 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| valsartan | Experimental | After 1-week screening period, all of the eligible patients receive valsartan 80mg/day for 2 weeks, then the dosage will be titrated to 160mg/day for further 8 weeks therapy for all of the subjects. Receives: Drug: Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline and week 2 in blood pressure at week 10
Measured: Baseline, 2 week and 10 weeks
Secondary outcomes (4)
Percentage of of patients who achieve BP<140/90mmHg
Measured: Baseline and 10 weeks
Change from baseline in ABPM (Ambulatory Blood Pressure Monitor) at week 10
Each subject will receive 24-hour ABPM at baseline and week 10.
Measured: Baseline and 10 weeks
Change from baseline in HBPM (Home Blood Pressure Monitor) at week 10
Each subject will receive HBPM at baseline, week 2, week 6 and week 10 respectively.For baseline HBPM, it was performed in the evening before visit 2 and in the morning of visit 2(before intake of study drug). in terms of the following 3 times of HBPM, they are performed during 5 days before each visit.
Measured: Baseline and 10 weeks
Number of patients with adverse events, serious adverse events
Measured: during 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2013
- Study completionJan 2013
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.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541189
- Sponsor's protocol ID
- CVAL489ACN14
- Status last verified
- Mar 2017
- First submitted
- 23 Feb 2012
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 8-week, Multi Center(10),Single Arm, Open-labeled Prospective Study of Valsartan 160 mg in 200 Mild to Moderate Chinese Hypertension Patients Forced Titrated From 2-week Therapy of Valsartan 80 mg.
- ClinicalTrials.gov ID
- NCT01541189
- Acronym / sponsor ID
- CVAL489ACN14
- Conditions
- Hypertension
- Keywords
- hypertension, valsartan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 29 Feb 2012 (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.
To evaluate efficacy and safety of valsartan 160mg in Chinese hypertensive patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| valsartan | Experimental | Drug: ValsartanAfter 1-week screening period, all of the eligible patients receive valsartan 80mg/day for 2 weeks, then the dosage will be titrated to 160mg/day for further 8 weeks therapy for all of the subjects. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Naive primary hypertension patients or primary hypertensive patients on mono antihypertensive therapy:
- All treatment-naive patients need to have 140mmHg≤MSSBP<180mmHg and 90mmHg≤MSDBP< 110mmHg at visit 1
- For patients on mono antihypertensive therapy, MSSBP/MSDBP should <160/100mmHg at visit 1 (the beginning of screening period); and at visit 2(the beginning of theraputic period), they should have MSSBP≥140 mmHg and <180mmHg AND MSDBP≥90 mmHg and <110mmHg
Key exclusion criteria (13 listed)
- Severe hypertension
- Malignant hypertension
- Secondary hypertension
- Renal dysfunction(serum creatinine > 2.0mg(176.8μmol/L)at visit 1)
- Hepatic disease
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 |
|---|---|---|
| Valsartan80 mg/day for 2 weeks, up-titrated to 160 mg/day for further 8 weeks | Drug | valsartan |
Primary outcome
Change from baseline and week 2 in blood pressure at week 10
Time frame: Baseline, 2 week and 10 weeks
4 secondary outcomes
Percentage of of patients who achieve BP<140/90mmHg
Time frame: Baseline and 10 weeks
Change from baseline in ABPM (Ambulatory Blood Pressure Monitor) at week 10
Time frame: Baseline and 10 weeks
Change from baseline in HBPM (Home Blood Pressure Monitor) at week 10
Time frame: Baseline and 10 weeks
Number of patients with adverse events, serious adverse events
Time frame: during 10 weeks
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 21 Mar 2017.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 Valsartan in people with Hypertension, run by Novartis Pharmaceuticals at 1 site in China.
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 13 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 21 Mar 2017. 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 China. 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?
Change from baseline and week 2 in blood pressure at week 10 (time frame: Baseline, 2 week and 10 weeks). 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 21 Mar 2017.