Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension
Information source: Bayer
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Adalat (Nifedipine, BAYA1040) (Drug); Diovan (Valsartan) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
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 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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mean Systolic BP and Diastolic BP on office Blood Pressure monitoring
Secondary outcome: Response rate (>/=10mmHg decrease of office SBP and >/=5mmHg decrease of office DBP)Control rate (Change in pulse pressure (difference between SBP and DBP) Reduction in Urinary microalbumin excretion(UAE) in patients with microalbuminuria Adverse Event reporting Vitals signs Laboratory tests
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 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 Criteria:
- 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 and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Beijing 100029, China; Recruiting
Beijing 100037, China; Not yet recruiting
Shanghai 200025, China; Recruiting
Jongno-gu, Korea, Republic of; Recruiting
Jung-gu, Korea, Republic of; Recruiting
Seoul 110-744, Korea, Republic of; Recruiting
Seoul 120-752, Korea, Republic of; Recruiting
Guangzhou, Guangdong, China; Not yet recruiting
Bucheon-si,, Gyeonggido, Korea, Republic of; Recruiting
Yangsan-si, Gyeongnam, Korea, Republic of; Not yet recruiting
Shijiazhuang, Hebei, China; Recruiting
Changsha, Hunan 410008, China; Not yet recruiting
Changsha, Hunan 410013, China; Recruiting
Nanjing, Jiangsu 210008, China; Not yet recruiting
Nanjing, Jiangsu, China; Recruiting
Kwangju, Korea 501757, Korea, Republic of; Not yet recruiting
Shenyang, Liaoning 110001, China; Not yet recruiting
Additional Information
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Starting date: February 2010
Last updated: September 9, 2010
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