Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension
Information source: Bayer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Adalat (Nifedipine, BAYA1040) (Drug); Diovan (Valsartan) (Drug)
Phase: Phase 4
Status: Not yet 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 systolic blood pressure (SBP) and diastolic
blood pressure (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 30 mg and Valsartan 80 mg Compared to Valsartan 160 mg Monotherapy in Patients Whose Blood Pressure is Not Well Controlled by Valsartan 80 mg Alone
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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
alone for at least 4 weeks.
- Patients on prior treatment with monotherapy diuretic, ACE-I or beta blocker with
inadequately controlled hypertension and switched to current low dose Valsartan 80 mg
are eligible.
- 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:
- Any anti-hypertensive treatment other than Valsartan 80 mg
- Cytochrome P450-3A4 inhibitors or inducers
- Potassium-sparing diuretics
- Severe hypertension (SBP/DBP >/= 180/110mmHg) 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 (determined by uristix)
- 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
China, China
Additional Information
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Starting date: January 2010
Ending date: February 2011
Last updated: October 9, 2009
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