Trial Condition(s):
Low-dose Nifedipine-Valsartan Combination compared to up-titrated Valsartan monotherapy in essential hypertension
14511
Not Available
Not Available
This will be a multi-center, prospective, randomized, open-label, parallel design, two arm comparator trial. In the proposed study, the investigators will compare low-dose combination therapy of Nifedipine GITS/OROS plus Valsartan with up-titrated monotherapy of Valsartan with respect to their blood pressure-decreasing effects in patients with essential hypertension.The study consists of a screening visit, followed by randomization and administration of either Nifedipine GITS/OROS 30 mg in combination with Valsartan 80 mg or Valsartan 160 mg for 12 weeks of treatment.The primary efficacy parameters will be mean SBP and DBP on office BP monitoring at 12 weeks of treatment compared to baseline.
- Men and women aged 18 - 75 years - Essential hypertension not well controlled by current low dose (80 mg) valsartan monotherapy for at least 4 weeks. Patients on prior treatment with monotherapy diuretic, ACE-I or beta blocker or an ARB other than valsartan and switched to the current low dose valsartan 80 mg monotherapy for at least 4 weeks are also eligible, provided the hypertension is still not well controlled. - Office systolic blood pressure (sitting) >140 mmHg (sitting for >/= 5 min., no cigarettes and/or coffee/tea for >/=30 min. before BP measurement). - BMI <33 kg/m2
- Participation in any clinical investigational drug study within the previous 12 weeks - Concomitant treatments with: 1. Any anti-hypertensive treatment other than Valsartan 80 mg 2. Cytochrome P450-3A4 inhibitors or inducers 3. Potassium-sparing diuretics - Severe hypertension (DBP >/= 110 mm Hg and/or SBP >/= 180 mm Hg) and/or evidence of secondary forms of hypertension - Any of the following cardiovascular diseases: - History of cardiovascular shock - Myocardial infarction or unstable angina within the previous 6 months - Severe cardiac valve disease - Past or present severe rhythm or conduction disorder. - Cerebrovascular ischemic event and/or history of intracerebral hemorrhage or subarachnoid hemorrhage (SAH) within the previous 12 months - Type 1 or 2 diabetes mellitus - Proteinuria - Uncorrected hypokalemia or hyperkalemia, sodium depletion and/or hypovolemia - Gastrointestinal disease resulting in the potential for malabsorption and/or severe gastro-intestinal tract narrowing; kock pouch (ileostomy after proctocolectomy) - Cholestasis or biliary obstruction - Liver disease or aspartate aminotransferase (AST) / alanine aminotransferase (ALT) levels >3 x upper limits of normal (ULN) - Renal failure, creatinine level >2.0 mg/dl
Locations | |
---|---|
Locations Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med School Shanghai, China, 200025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The First hospital of China Medical University Shenyang, China, 110001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 1st Affiliated Hosp., of Nanjing Medical Univ. Nanjing, China, 210029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Third Xiangya Hospital of Central South University Changsha, China, 410013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul St. Mary's Hospital Seoul, South Korea, 110-744 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pusan National University Hospital Yangsan-si, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chungnam National University Hospital Jung-gu, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chonnam National University Hospital Donggu,, South Korea, 501757 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations China-Japan Friendship Hospital Beijing, China, 100029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cardiovascular Institute and Fuwai Hospital, CAMS & PUMC Beijing, China, 100037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Xiangya Hospital of Central South University Changsha, China, 410008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The First Affiliated Hospital of Sun Yat-Sen University Guangzhou, China, 510080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations People's Hospital of Hebei Province Shijiazhuang, China, 050051 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Drum Tower Hospital of Nanjing University Medical School Nanjing, China, 210008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Severance Hospital, Yonsei University College of Medicine Seoul, South Korea, 120-752 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul National University Hospital Jongno-gu, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Catholic University of Korea Kangnam St. Mary's Hospital Bucheon-si,, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Randomized,open-label,parallel design comparator study of effect of Nifedipine GITS/OROS (Adalat) 30 mg in combination with Valsartan (Diovan) 80 mg compared to Valsartan (Diovan) 160 mg monotherapy in patients whose blood pressure is not well controlled by Valsartan 80 mg alone
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2