Status:
COMPLETED
Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension
Lead Sponsor:
Bayer
Conditions:
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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 Nifed...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Participation in any clinical investigational drug study within the previous 12 weeks
- Concomitant treatments with:
- Any anti-hypertensive treatment other than Valsartan 80 mg
- Cytochrome P450-3A4 inhibitors or inducers
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00993109
Start Date
February 1 2010
End Date
May 1 2011
Last Update
June 5 2014
Active Locations (17)
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1
Guangzhou, Guangdong, China, 510080
2
Shijiazhuang, Hebei, China, 050051
3
Changsha, Hunan, China, 410008
4
Changsha, Hunan, China, 410013