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

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

Condition Intervention Phase
Drug: Adalat (Nifedipine, BAYA1040)
Drug: Diovan (Valsartan)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Mean Systolic BP and Diastolic BP on office Blood Pressure monitoring [ Time Frame: Baseline and 12 weeks of treatment ]

Secondary Outcome Measures:
  • Response rate (>/=10mmHg decrease of office SBP and >/=5mmHg decrease of office DBP) [ Time Frame: 8 and 12 weeks of treatment ]
  • Control rate (</=140/90 of office BP) [ Time Frame: 8 and 12 weeks of treatment ]
  • Change in pulse pressure (difference between SBP and DBP) [ Time Frame: 12 weeks of treatment ]
  • Reduction in Urinary microalbumin excretion(UAE) in patients with microalbuminuria [ Time Frame: Baseline and 12 weeks of treatment ]
  • Adverse Event reporting [ Time Frame: At the start, every 4 weeks during treatment and at the end of treatment ]
  • Vitals signs [ Time Frame: At the start, every 4 weeks during treatment and at the end of treatment ]
  • Laboratory tests [ Time Frame: At the start and at the end of treatment ]

Enrollment: 360
Study Start Date: February 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Adalat (Nifedipine, BAYA1040)
Nifedipine GITS/OROS 30 mg OM + Valsartan 80 mg OM
Active Comparator: Arm 2 Drug: Diovan (Valsartan)
Valsartan 160 mg OM (Two Valsartan 80mg tablets)


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00993109

China, Guangdong
Guangzhou, Guangdong, China, 510080
China, Hebei
Shijiazhuang, Hebei, China, 050051
China, Hunan
Changsha, Hunan, China, 410008
Changsha, Hunan, China, 410013
China, Jiangsu
Nanjing, Jiangsu, China, 210008
Nanjing, Jiangsu, China, 210029
China, Liaoning
Shenyang, Liaoning, China, 110001
Beijing, China, 100029
Beijing, China, 100037
Shanghai, China, 200025
Korea, Republic of
Donggu,, Gwangju Gwang''yeogsi, Korea, Republic of, 501757
Bucheon-si,, Gyeonggido, Korea, Republic of
Yangsan-si, Gyeongnam, Korea, Republic of
Jongno-gu, Korea, Republic of
Jung-gu, Korea, Republic of
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bayer Identifier: NCT00993109     History of Changes
Other Study ID Numbers: 14511
ADVISE ( Other Identifier: Company Internal )
Study First Received: October 9, 2009
Last Updated: June 4, 2014

Keywords provided by Bayer:
Nifedipine GITS/OROS (Adalat®)
Valsartan (Diovan®)

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs processed this record on April 21, 2017