Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hanmi Pharmaceutical Company Limited
This study is designed as a multi-center, double-blinded, randomized, phase 3 clinical trial to evaluate the efficacy and safety of Co-administered HGP0904, HGP0608 and HGP0816 in Patients with Hypertension and Dyslipidemia
3. at Visit 2 : after TLC (after 4weeks) 1) BP: 80 mmHg ≤ sitDBP \< 110mmHg 2) Cholesterol : following risk category (Cardiovascular Risk category) A : CHD risk factor 0 - 1, 160mg/dL ≤ LDL-C ≤ 250mg/dL B①: CHD risk factor≥2 and 10 year risk \<10%, 160mg/dL ≤ LDL-C ≤ 250mg/dL B②: CHD risk factor≥2 and 10 year risk =10-20%, 130mg/dL ≤ LDL-C ≤ 250mg/dL C : CHD/CHD risk equivalents\* or 10 year risk\>20 ,100mg/dL ≤ LDL-C ≤ 250mg/dL 3) TG \< 400mg/dL 4. Patients understood the contents and purpose of this trial and signed informed consent form
You may not be if
1. At Visit 1, BP difference SBP ≥20mmHg or DBP ≥10mmHg
2. Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA. reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy
3. Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin
4. CPK normal range ≥ 3times
5. Uncontrolled primary hypothyroidism(TSH normal range ≥ 2 times)
6. Renal disease or suspected renal disease (Scr ≥ 2mg/dL, AST or ALT≥2 times)
7. Active gout or hyperuricemia(at Visit 1, uric acid \> 9mg/dL)
8. IDDM or uncontrolled diabetes mellitus (HbA1c\>9%)
9. ventricular arrhythmia
10. medical history
* severe cerebrovascular disease within 6 months (cerebral infarction, cerebral hemorrhage), hypertension
