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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2011

Intervention(s) in this Clinical Trial

• Drug: Adalat (Nifedipine, BAYA1040)
  • Nifedipine GITS/OROS 30 mg OM + Valsartan 80 mg OM
• Drug: Diovan (Valsartan)
  • Valsartan 160 mg OM (Two Valsartan 80mg tablets)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Active Comparator: Arm 2

Primary Measures

• Mean Systolic BP and Diastolic BP on office Blood Pressure monitoring
  • Time Frame: Baseline and 12 weeks of treatment
    Safety Issue?: No

Secondary Measures

• Response rate (>/=10mmHg decrease of office SBP and >/=5mmHg decrease of office DBP)
  • Time Frame: 8 and 12 weeks of treatment
    Safety Issue?: No
• Control rate (</=140/90 of office BP)
  • Time Frame: 8 and 12 weeks of treatment
    Safety Issue?: No
• Change in pulse pressure (difference between SBP and DBP)
  • Time Frame: 12 weeks of treatment
    Safety Issue?: No
• Reduction in Urinary microalbumin excretion(UAE) in patients with microalbuminuria
  • Time Frame: Baseline and 12 weeks of treatment
    Safety Issue?: No
• Adverse Event reporting
  • Time Frame: At the start, every 4 weeks during treatment and at the end of treatment
    Safety Issue?: Yes
• Vitals signs
  • Time Frame: At the start, every 4 weeks during treatment and at the end of treatment
    Safety Issue?: Yes
• Laboratory tests
  • Time Frame: At the start and at the end of treatment
    Safety Issue?: Yes

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:
• 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 (determined by urine test strips)
• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Overall Contact: Bayer Clinical Trials Contact  clinical-trials-contact@bayerhealthcare.com

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00993109

Study ID Number: 14511

ClinicalTrials.gov Identifier: NCT00993109

Health Authority: China: State Food and Drug Administration

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