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

June 4, 2014 updated by: Bayer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100029
      • Beijing, China, 100037
      • Shanghai, China, 200025
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
    • Hunan
      • Changsha, Hunan, China, 410013
      • Changsha, Hunan, China, 410008
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
      • Nanjing, Jiangsu, China, 210029
    • Liaoning
      • Shenyang, Liaoning, China, 110001
  • 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
    • Gwangju Gwang''yeogsi
      • Donggu,, Gwangju Gwang''yeogsi, Korea, Republic of, 501757
    • Gyeonggido
      • Bucheon-si,, Gyeonggido, Korea, Republic of
    • Gyeongnam
      • Yangsan-si, Gyeongnam, Korea, Republic of

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Drug: Diovan (Valsartan)
Valsartan 160 mg OM (Two Valsartan 80mg tablets)
Experimental: Arm 1
Drug: Adalat (Nifedipine, BAYA1040)
Nifedipine GITS/OROS 30 mg OM + Valsartan 80 mg OM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Systolic BP and Diastolic BP on office Blood Pressure monitoring
Time Frame: Baseline and 12 weeks of treatment
Baseline and 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate (>/=10mmHg decrease of office SBP and >/=5mmHg decrease of office DBP)
Time Frame: 8 and 12 weeks of treatment
8 and 12 weeks of treatment
Control rate (</=140/90 of office BP)
Time Frame: 8 and 12 weeks of treatment
8 and 12 weeks of treatment
Change in pulse pressure (difference between SBP and DBP)
Time Frame: 12 weeks of treatment
12 weeks of treatment
Reduction in Urinary microalbumin excretion(UAE) in patients with microalbuminuria
Time Frame: Baseline and 12 weeks of treatment
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
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
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
At the start and at the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

October 9, 2009

First Submitted That Met QC Criteria

October 9, 2009

First Posted (Estimate)

October 12, 2009

Study Record Updates

Last Update Posted (Estimate)

June 5, 2014

Last Update Submitted That Met QC Criteria

June 4, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14511
  • ADVISE (Company Internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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