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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:
Bayer
ClinicalTrials.gov Identifier:
NCT00993109
First received: October 9, 2009
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993109

Locations
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
China
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
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medical Affairs Therapeutic area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00993109     History of Changes
Other Study ID Numbers: 14511, ADVISE
Study First Received: October 9, 2009
Last Updated: June 15, 2012
Health Authority: China: Food and Drug Administration
Korea: Korean Food and Drug Administration

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Nifedipine
Valsartan
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 16, 2013