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Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00993109
First received: October 9, 2009
Last updated: June 4, 2014
Last verified: June 2014

October 9, 2009
June 4, 2014
February 2010
May 2011   (final data collection date for primary outcome measure)
Mean Systolic BP and Diastolic BP on office Blood Pressure monitoring [ Time Frame: Baseline and 12 weeks of treatment ] [ Designated as safety issue: No ]
Mean Systolic BP and Diastolic BP on office Blood Pressure monitoring [ Time Frame: Baseline and 12 weeks of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00993109 on ClinicalTrials.gov Archive Site
  • Response rate (>/=10mmHg decrease of office SBP and >/=5mmHg decrease of office DBP) [ Time Frame: 8 and 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Control rate (</=140/90 of office BP) [ Time Frame: 8 and 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Change in pulse pressure (difference between SBP and DBP) [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Reduction in Urinary microalbumin excretion(UAE) in patients with microalbuminuria [ Time Frame: Baseline and 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Adverse Event reporting [ Time Frame: At the start, every 4 weeks during treatment and at the end of treatment ] [ Designated as safety issue: Yes ]
  • Vitals signs [ Time Frame: At the start, every 4 weeks during treatment and at the end of treatment ] [ Designated as safety issue: Yes ]
  • Laboratory tests [ Time Frame: At the start and at the end of treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • 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)
  • Experimental: Arm 1
    Intervention: Drug: Adalat (Nifedipine, BAYA1040)
  • Active Comparator: Arm 2
    Intervention: Drug: Diovan (Valsartan)
Ke YN, Dong YG, Ma SP, Yuan H, Ihm SH, Baek SH; ADVISE study group. Improved blood pressure control with nifedipine GITS/valsartan combination versus high-dose valsartan monotherapy in mild-to-moderate hypertensive patients from Asia: results from the ADVISE study, a randomized trial. Cardiovasc Ther. 2012 Dec;30(6):326-32. doi: 10.1111/1755-5922.12003.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
May 2011
May 2011   (final data collection date for primary outcome measure)

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 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 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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China,   Korea, Republic of
 
NCT00993109
14511, ADVISE
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP