HypertensionNCT04398771
To Evaluate Safety and Effectiveness of RovatitanTab.
An observational study of Hypertension and Hyperlipidemias, run by LG Chem.
Trial summary
To evaluate the safety and effectiveness of a fixed-dose combination containing valsartan and rosuvastatin (Rovatitan® Tablet) in patient with hypertension and hypercholesterolemia Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Hyperlipidemias
- What is being tested?
- Rosuvastatin/Valsartan
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 May 2022
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have hypertension and hyperlipidemia
Who may be able to join
- Patients who have hypertension and hyperlipidemia and older than 19 years
- Patients who undertstand purpose and method of study, agree with study
Who cannot join
- Patients who have been administered Rosuvastatin/Valsartan as a anti- hyperlipiddemic/anti-hypertensive drugs
- Uncontrolled hypertension (SBP>=180mmHg or DBP>=110mmHg)
- Patients who participated another clinical study or observational study 3 months ago.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Single-arm, Prospective, Observational Study to Evaluate the Safety and Effectiveness of a Fixed-dose Combination Containing Valsartan and Rosuvastatin (Rovatitan® Tablet) in Patient With Hypertension and Hypercholesterolemia
To evaluate the safety and effectiveness of a fixed-dose combination containing valsartan and rosuvastatin (Rovatitan® Tablet) in patient with hypertension and hypercholesterolemia
Read the detailed description
- Effectiveness: the ratio of patients who reach target BP or LDL-cholesterol
- Safety: we will collect safety data
- Conditions
- Hypertension, Hyperlipidemias
- Being tested
- Rosuvastatin/Valsartan
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin/ValsartanDrug
Also called Rovatitan Tab.
Rovatitan QD for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Rovatitan 5/80mg (Rosuvastatin 5mg/Valsartan 80mg) Rovatitan 5/160mg (Rosuvastatin 5mg/Valsartan 160mg) Rovatitan 10/80mg (Rosuvastatin 10mg/Valsartan 80mg) Rovatitan 10/160mg (Rosuvastatin 10mg/Valsartan 160mg) Rovatitan 20/80mg (Rosuvastatin 20mg/Valsartan 80mg) Rovatitan 20/160mg (Rosuvastatin 20mg/Valsartan 160mg) Receives: Drug: Rosuvastatin/Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of patients who reach the target BP
SBP/DBP<140/90mmHg (<60years), SBP/DBP<150/90mmHg (>=60years)
Measured: 12weeks
The ratio of patients who reach the target LDLcholesterol
target LDL refered to Hyperlipidemia pharmacotherapy
Measured: 12weeks
Secondary outcomes (1)
The ratio of patients who reach the target BP and LDL-c
SBP/DBP<140/90mmHg (<60years), SBP/DBP<150/90mmHg (>=60years), target LDL
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion31 May 2022 (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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kang seokmin, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398771
- Sponsor's protocol ID
- LG-VROS001
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm, Prospective, Observational Study to Evaluate the Safety and Effectiveness of a Fixed-dose Combination Containing Valsartan and Rosuvastatin (Rovatitan® Tablet) in Patient With Hypertension and Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT04398771
- Acronym / sponsor ID
- LG-VROS001
- Conditions
- Hypertension, Hyperlipidemias
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 21 May 2020 (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.
To evaluate the safety and effectiveness of a fixed-dose combination containing valsartan and rosuvastatin (Rovatitan® Tablet) in patient with hypertension and hypercholesterolemia
Detailed description
- Effectiveness: the ratio of patients who reach target BP or LDL-cholesterol
- Safety: we will collect safety data
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Drug: Rosuvastatin/ValsartanRovatitan 5/80mg (Rosuvastatin 5mg/Valsartan 80mg) Rovatitan 5/160mg (Rosuvastatin 5mg/Valsartan 160mg) Rovatitan 10/80mg (Rosuvastatin 10mg/Valsartan 80mg) Rovatitan 10/160mg (Rosuvastatin 10mg/Valsartan 160mg) Rovatitan 20/80mg (Rosuvastatin 20mg/Valsartan 80mg) Rovatitan 20/160mg (Rosuvastatin 20mg/Valsartan 160mg) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have hypertension and hyperlipidemia
Key inclusion criteria (2 listed)
- Patients who have hypertension and hyperlipidemia and older than 19 years
- Patients who undertstand purpose and method of study, agree with study
Key exclusion criteria (3 listed)
- Patients who have been administered Rosuvastatin/Valsartan as a anti- hyperlipiddemic/anti-hypertensive drugs
- Uncontrolled hypertension (SBP>=180mmHg or DBP>=110mmHg)
- Patients who participated another clinical study or observational study 3 months ago.
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 |
|---|---|---|
| Rosuvastatin/ValsartanAlso: Rovatitan Tab.Rovatitan QD for 12 weeks | Drug | Treatment |
Primary outcome
The ratio of patients who reach the target BP
Time frame: 12weeks
SBP/DBP<140/90mmHg (<60years), SBP/DBP<150/90mmHg (>=60years)
The ratio of patients who reach the target LDLcholesterol
Time frame: 12weeks
target LDL refered to Hyperlipidemia pharmacotherapy
1 secondary outcome
The ratio of patients who reach the target BP and LDL-c
Time frame: 12weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
Kang seokmin principal investigator
Severance Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Hyperlipidemias, run by LG Chem.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact songyi Park (=82-2-6987-4195, songyi-park@lgchem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of patients who reach the target BP (time frame: 12weeks). The study lists 2 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 21 May 2020.