Hypertension,Phase 3NCT01918332

Efficacy and Safety of Valsartan 160mg and Rosuvastatin 20mg in Patients With Hypertension and Hyperlipidemia

A Phase 3 study testing Valsartan 160mg and Rosuvastatin 20mg in people with Hypertension, and Hyperlipidemia, run by LG Life Sciences at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to evaluate the efficacy and safety of the coadministration of valsartan (Diovan®) 160mg and rosuvastatin (Crestor®) 20mg in comparison to each component administered alone in patients with hypertension and hyperlipidemia. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Hypertension,, Hyperlipidemia
What is being tested?: Valsartan 160mg and Rosuvastatin 20mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 168 participants
Where: 1 siteSouth Korea
Study dates: Apr 2012to Mar 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patient aged 20-80 years who has hypertension and hyperlipidemia
Patient who has a Hypertension
Patient who has a Hyperlipidemia according to NCEP-ATP III guideline(2004)
Patient who signed the Informed Consent Form after receiving an explanation on the purpose, methods, and effect of the study

Who cannot join

If blood pressure and fasting serum lipid level measured at screening and Visit 2 (0 week) satisfy the following criteria 1) sitSBP≥180mmHg or sitDBP≥110mmHg (For high risk group, sitSBP≥ 160mmHg or sitDBP ≥100mmHg ) 2) LDL-C>250mg/dL , or TG≥ 400mg/dL
If sitSBP difference between the right and left arms >20mmHg or sitDBP difference between the right and left arms > 10mmHg at screening
When blood pressure is repeatedly measured from the selected arm at screening, if sitSBP difference ≥ 20mmHg or sitDBP difference ≥10mmHg
Patient with orthostatic hypotension accompanying symptoms at screening (decrease in sitDBP ≥10mmHg or decrease in sitSBP ≥ 20mmHg )

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Yonsei University Health System Severance Hospital
Seoul

Other trials in South Korea

About this study

Official title: A Multicenter, Randomized, Factorial, Double-blinded, Double-dummy Phase Ⅲ Trial to Evaluate the Efficacy and Safety of the Coadministration of Valsartan 160mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone in Patients With Hypertension and Hyperlipidemia

Conditions: Hypertension,, Hyperlipidemia
Being tested: Valsartan 160mg, Rosuvastatin 20mg, Valsartan 160mg placebo, Rosuvastatin 20mg placebo
Medical subject headings: Hypertension, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Valsartan 160mgDrug
Also called Diovan
Rosuvastatin 20mgDrug
Also called Crestor
Valsartan 160mg placeboDrug
Rosuvastatin 20mg placeboDrug

Study groups in NCT01918332
Study group	Role	What they receive
Valsartan 160mg, Rosuvastatin 20mg	Experimental	Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks. Receives: Drug: Valsartan 160mg; Drug: Rosuvastatin 20mg
Valsartan 160mg, Rosuvastatin 20mg placebo	Active comparator	Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks. Receives: Drug: Valsartan 160mg; Drug: Rosuvastatin 20mg placebo
Valsartan 160mg placebo, Rosuvastatin 20mg	Active comparator	Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks. Receives: Drug: Rosuvastatin 20mg; Drug: Valsartan 160mg placebo
Placebo	Placebo comparator	Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks. Receives: Drug: Valsartan 160mg placebo; Drug: Rosuvastatin 20mg placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

sitDBP Changes at Week 8 From Baseline
sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline
Measured: 8 weeks
LDL-C Percentage Changes at Week 8 From Baseline
LDL-C percentage changes of the rosuvastatin 20mg and rosuvastatin placebo groups at Week 8 from baseline
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Mar 2013

First posted7 Aug 2013 (estimated)
Study startApr 2012
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hypertension,Studies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01918332
Sponsor's protocol ID: LG-VRCL002
Status last verified: Dec 2014
First submitted: 5 Aug 2013
Last updated: 15 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Factorial, Double-blinded, Double-dummy Phase Ⅲ Trial to Evaluate the Efficacy and Safety of the Coadministration of Valsartan 160mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone in Patients With Hypertension and Hyperlipidemia
ClinicalTrials.gov ID: NCT01918332
Acronym / sponsor ID: LG-VRCL002
Conditions: Hypertension,, Hyperlipidemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 168 participants (actual)
Lead sponsor: LG Life SciencesIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 7 Aug 2013 (estimated)
Results: Posted 15 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Valsartan 160mg, Rosuvastatin 20mg	Experimental	Drug: Valsartan 160mg, Drug: Rosuvastatin 20mgBoth Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.
Valsartan 160mg, Rosuvastatin 20mg placebo	Active comparator	Drug: Valsartan 160mg, Drug: Rosuvastatin 20mg placeboIntervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg placebo, Rosuvastatin 20mg	Active comparator	Drug: Rosuvastatin 20mg, Drug: Valsartan 160mg placeboIntervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.
Placebo	Placebo comparator	Drug: Valsartan 160mg placebo, Drug: Rosuvastatin 20mg placeboIntervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patient aged 20-80 years who has hypertension and hyperlipidemia
Patient who has a Hypertension
Patient who has a Hyperlipidemia according to NCEP-ATP III guideline(2004)
Patient who signed the Informed Consent Form after receiving an explanation on the purpose, methods, and effect of the study

Key exclusion criteria (4 listed)

If blood pressure and fasting serum lipid level measured at screening and Visit 2 (0 week) satisfy the following criteria 1) sitSBP≥180mmHg or sitDBP≥110mmHg (For high risk group, sitSBP≥ 160mmHg or sitDBP ≥100mmHg ) 2) LDL-C>250mg/dL , or TG≥ 400mg/dL
If sitSBP difference between the right and left arms >20mmHg or sitDBP difference between the right and left arms > 10mmHg at screening
When blood pressure is repeatedly measured from the selected arm at screening, if sitSBP difference ≥ 20mmHg or sitDBP difference ≥10mmHg
Patient with orthostatic hypotension accompanying symptoms at screening (decrease in sitDBP ≥10mmHg or decrease in sitSBP ≥ 20mmHg )

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
Valsartan 160mgAlso: Diovan	Drug	Valsartan 160mg, Rosuvastatin 20mg, Valsartan 160mg, Rosuvastatin 20mg placebo
Rosuvastatin 20mgAlso: Crestor	Drug	Valsartan 160mg placebo, Rosuvastatin 20mg, Valsartan 160mg, Rosuvastatin 20mg
Valsartan 160mg placebo	Drug	Placebo, Valsartan 160mg placebo, Rosuvastatin 20mg
Rosuvastatin 20mg placebo	Drug	Placebo, Valsartan 160mg, Rosuvastatin 20mg placebo

Primary outcome

sitDBP Changes at Week 8 From Baseline
Time frame: 8 weeks
sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline
LDL-C Percentage Changes at Week 8 From Baseline
Time frame: 8 weeks
LDL-C percentage changes of the rosuvastatin 20mg and rosuvastatin placebo groups at Week 8 from baseline

Results and safety

Results posted to the registry on 15 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Valsartan 160mg, Rosuvastatin 20mg	43	35
Valsartan 160mg, Rosuvastatin 20mg Placebo	41	36
Valsartan 160mg Placebo, Rosuvastatin 20mg	39	30
Placebo	45	38

Primary outcome: sitDBP Changes at Week 8 From Baseline

Time frame: 8 weeks. Least squares mean (95% Confidence Interval). Unit: mmHg

Measure	V160+R20 & V160 n = 81	R20 & Placebo n = 79
Value	-9.24 (-10.88 to -7.61)	-2.9 (-4.55 to -1.24)

Population analysed: FAS

Primary outcome: LDL-C Percentage Changes at Week 8 From Baseline

Time frame: 8 weeks. Least squares mean (95% Confidence Interval). Unit: percent change

Measure	V160+R20 & R20 n = 76	V160 & Placebo n = 84
Value	-49.91 (-53.34 to -46.47)	-2.38 (-5.65 to 0.88)

Population analysed: FAS

Adverse events

Time frame: 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Valsartan 160mg, Rosuvastatin 20mg	1 of 43 (2.3%)	10 of 43 (23.3%)	Not reported
Valsartan 160mg, Rosuvastatin 20mg Placebo	0 of 41 (0%)	7 of 41 (17.1%)	Not reported
Valsartan 160mg Placebo, Rosuvastatin 20mg	0 of 37 (0%)	4 of 37 (10.8%)	Not reported
Placebo	0 of 45 (0%)	5 of 45 (11.1%)	Not reported

Limitations and caveats (from the sponsor): Withdrawal(discontinuation) leading to smaller number of per-protocol set than full analysis set. The violation of protocol was the criterion of subjects' withdrawal.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Valsartan 160mg and Rosuvastatin 20mg in people with Hypertension, and Hyperlipidemia, run by LG Life Sciences at 1 site in South Korea.

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 4 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 15 Dec 2014. 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 South Korea. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

sitDBP Changes at Week 8 From Baseline (time frame: 8 weeks). 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?

On the ClinicalTrials.gov record for NCT01918332.

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 Dec 2014.