check_circleStudy Completed

Hypertension

Bayer Identifier:

14511

ClinicalTrials.gov Identifier:

NCT00993109

EudraCT Number:

Not Available

EU CT Number:

Not Available
Low-dose Nifedipine-Valsartan Combination compared to up-titrated Valsartan monotherapy in essential hypertension

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - 75 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
360
Trial Dates
February 2010 - May 2011
Phase
Phase 4
Could I Receive a placebo
No
Products
Adalat GITS (Nifedipine, BAYA1040)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med SchoolShanghai, 200025, China
Terminated
The First hospital of China Medical UniversityShenyang, 110001, China
Completed
1st Affiliated Hosp., of Nanjing Medical Univ.Nanjing, 210029, China
Completed
The Third Xiangya Hospital of Central South UniversityChangsha, 410013, China
Completed
Seoul St. Mary's HospitalSeoul, 110-744, Korea, Republic Of
Completed
Pusan National University HospitalYangsan-si, Korea, Republic Of
Completed
Chungnam National University HospitalJung-gu, Korea, Republic Of
Completed
Chonnam National University HospitalDonggu,, 501757, Korea, Republic Of
Completed
China-Japan Friendship HospitalBeijing, 100029, China
Completed
Cardiovascular Institute and Fuwai Hospital, CAMS & PUMCBeijing, 100037, China
Completed
The Xiangya Hospital of Central South UniversityChangsha, 410008, China
Completed
The First Affiliated Hospital of Sun Yat-Sen UniversityGuangzhou, 510080, China
Completed
People's Hospital of Hebei ProvinceShijiazhuang, 050051, China
Completed
Drum Tower Hospital of Nanjing University Medical SchoolNanjing, 210008, China
Completed
Severance Hospital, Yonsei University College of MedicineSeoul, 120-752, Korea, Republic Of
Completed
Seoul National University HospitalJongno-gu, Korea, Republic Of
Completed
The Catholic University of Korea Kangnam St. Mary's HospitalBucheon-si,, Korea, Republic Of

Primary Outcome

  • Mean Systolic BP and Diastolic BP on office Blood Pressure monitoring
    date_rangeTime Frame:
    Baseline and 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

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

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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