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CompletedNCT01918332Updated Dec 15, 2014Results posted

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

A Phase 3 interventional study of Valsartan 160mg and Rosuvastatin 20mg in Hypertension, and Hyperlipidemia, sponsored by LG Life Sciences. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-12-15.

Sponsored by LG Life Sciences · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension,
  • Hyperlipidemia
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 168 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

LG Life Sciences is the lead sponsor of 75 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. If sitSBP difference between the right and left arms >20mmHg or sitDBP difference between the right and left arms > 10mmHg at screening
  3. When blood pressure is repeatedly measured from the selected arm at screening, if sitSBP difference ≥ 20mmHg or sitDBP difference ≥10mmHg
  4. Patient with orthostatic hypotension accompanying symptoms at screening (decrease in sitDBP ≥10mmHg or decrease in sitSBP ≥ 20mmHg )
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
168 participants (actual)

Study arms

  • Experimental
    Valsartan 160mg, Rosuvastatin 20mg

    Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.

    Drug: Valsartan 160mg · Drug: Rosuvastatin 20mg

  • Active comparator
    Valsartan 160mg, Rosuvastatin 20mg placebo

    Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.

    Drug: Valsartan 160mg · Drug: Rosuvastatin 20mg placebo

  • Active comparator
    Valsartan 160mg placebo, Rosuvastatin 20mg

    Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.

    Drug: Rosuvastatin 20mg · Drug: Valsartan 160mg placebo

  • Placebo comparator
    Placebo

    Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.

    Drug: Valsartan 160mg placebo · Drug: Rosuvastatin 20mg placebo

Interventions

  • DrugValsartan 160mg

    Also known as: Diovan

  • DrugRosuvastatin 20mg

    Also known as: Crestor

  • DrugValsartan 160mg placebo
  • DrugRosuvastatin 20mg placebo
06

What researchers measure

Primary outcomes

  1. sitDBP Changes at Week 8 From Baseline

    sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline

    Time frame: 8 weeks

  2. 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

    Time frame: 8 weeks

07

Results

Posted Dec 15, 2014
Limitations and caveats
Withdrawal(discontinuation) leading to smaller number of per-protocol set than full analysis set. The violation of protocol was the criterion of subjects' withdrawal.

Participant flow

Participant flow — Overall Study
MilestoneValsartan 160mg, Rosuvastatin 20mgValsartan 160mg, Rosuvastatin 20mg PlaceboValsartan 160mg Placebo, Rosuvastatin 20mgPlacebo
Started43413945
Completed35363038
Not completed8597
Withdrew: Adverse event0001
Withdrew: Withdrawal by subject2323
Withdrew: Protocol violation6263
Withdrew: Lipid result by central lab did not meet0010

Outcome measures

PrimarysitDBP Changes at Week 8 From Baseline

sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline

Time frame:
8 weeks
Reported as:
Least squares mean · mmHg
sitDBP Changes at Week 8 From Baseline
mmHgV160+R20 & V160R20 & Placebo
sitDBP Changes at Week 8 From Baseline-9.24 (-10.88 to -7.61)-2.9 (-4.55 to -1.24)
PrimaryLDL-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

Time frame:
8 weeks
Reported as:
Least squares mean · percent change
LDL-C Percentage Changes at Week 8 From Baseline
percent changeV160+R20 & R20V160 & Placebo
LDL-C Percentage Changes at Week 8 From Baseline-49.91 (-53.34 to -46.47)-2.38 (-5.65 to 0.88)

Adverse events

Collected over 12~14 weeks (4-6 weeks of Therapeutic Lifestyle Change + 8 weeks of Treatment period). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Valsartan 160mg, Rosuvastatin 20mg—1/43 (2.3%)10/43 (23.3%)
Valsartan 160mg, Rosuvastatin 20mg Placebo—0/41 (0%)7/41 (17.1%)
Valsartan 160mg Placebo, Rosuvastatin 20mg—0/37 (0%)4/37 (10.8%)
Placebo—0/45 (0%)5/45 (11.1%)
Most frequent serious events
Most frequent serious events
EventValsartan 160mg, Rosuvastatin 20mgValsartan 160mg, Rosuvastatin 20mg PlaceboValsartan 160mg Placebo, Rosuvastatin 20mgPlacebo
NauseaGastrointestinal disorders1/430/410/370/45
Most frequent other events
Showing 10 of 24
Most frequent other events
EventValsartan 160mg, Rosuvastatin 20mgValsartan 160mg, Rosuvastatin 20mg PlaceboValsartan 160mg Placebo, Rosuvastatin 20mgPlacebo
headacheNervous system disorders2/430/410/373/45
dyspepsiaGastrointestinal disorders1/432/410/370/45
chest discomfortGeneral disorders0/432/410/370/45
dizzinessNervous system disorders1/432/410/370/45
nauseaGastrointestinal disorders2/430/410/370/45
conjunctival haemorrhageEye disorders0/430/411/370/45
astheniaGeneral disorders0/431/411/370/45
chest painGeneral disorders0/430/411/370/45
urinary tract infectionInfections and infestations0/430/411/370/45
alanine aminotransferase increasedInvestigations1/430/411/371/45

Baseline characteristics

Full Analysis Set

Age, Categorical
Age, Categorical(Participants)Valsartan 160mg, Rosuvastatin 20mgValsartan 160mg, Rosuvastatin 20mg PlaceboValsartan 160mg Placebo, Rosuvastatin 20mgPlaceboTotal
<=18 years00000
Between 18 and 65 years26242129100
>=65 years1516141560
Sex: Female, Male
Sex: Female, Male(Participants)Valsartan 160mg, Rosuvastatin 20mgValsartan 160mg, Rosuvastatin 20mg PlaceboValsartan 160mg Placebo, Rosuvastatin 20mgPlaceboTotal
Female161471047
Male25262834113
08

Study locations

1 site
  • Yonsei University Health System Severance Hospital
    Seoul, Korea, Republic of
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01918332
Lead sponsor
LG Life Sciences
Responsible party
Sponsor
First posted
Aug 7, 2013
Start date
Apr 2012
Primary completion
Mar 2013
Completion
Mar 2013
Results posted
Dec 15, 2014
Last update
Dec 15, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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