Phase 3
Completed N=168
Efficacy and Safety of Valsartan 160mg and Rosuvastatin 20mg in Patients With Hypertension and Hyperlipidemia
Source: ClinicalTrials.gov NCT01918332 ↗Enrolled (actual)
168
Serious AEs
0.6%
Results posted
Dec 2014
Primary outcomePrimary: sitDBP Changes at Week 8 From Baseline — -9.24; -2.9 mmHg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY sitDBP Changes at Week 8 From Baseline |
-9.24; -2.9 | — |
| PRIMARY LDL-C Percentage Changes at Week 8 From Baseline |
-49.91; -2.38 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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 )
Data sourced from ClinicalTrials.gov (NCT01918332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.