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
2 other identifiers
interventional
360
2 countries
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hypertension
Started Feb 2010
Shorter than P25 for phase_4 hypertension
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2009
CompletedFirst Posted
Study publicly available on registry
October 12, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedJune 5, 2014
June 1, 2014
1.2 years
October 9, 2009
June 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Systolic BP and Diastolic BP on office Blood Pressure monitoring
Baseline and 12 weeks of treatment
Secondary Outcomes (7)
Response rate (>/=10mmHg decrease of office SBP and >/=5mmHg decrease of office DBP)
8 and 12 weeks of treatment
Control rate (</=140/90 of office BP)
8 and 12 weeks of treatment
Change in pulse pressure (difference between SBP and DBP)
12 weeks of treatment
Reduction in Urinary microalbumin excretion(UAE) in patients with microalbuminuria
Baseline and 12 weeks of treatment
Adverse Event reporting
At the start, every 4 weeks during treatment and at the end of treatment
- +2 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Participation in any clinical investigational drug study within the previous 12 weeks
- Concomitant treatments with:
- Any anti-hypertensive treatment other than Valsartan 80 mg
- Cytochrome P450-3A4 inhibitors or inducers
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (17)
Unknown Facility
Guangzhou, Guangdong, 510080, China
Unknown Facility
Shijiazhuang, Hebei, 050051, China
Unknown Facility
Changsha, Hunan, 410008, China
Unknown Facility
Changsha, Hunan, 410013, China
Unknown Facility
Nanjing, Jiangsu, 210008, China
Unknown Facility
Nanjing, Jiangsu, 210029, China
Unknown Facility
Shenyang, Liaoning, 110001, China
Unknown Facility
Beijing, 100029, China
Unknown Facility
Beijing, 100037, China
Unknown Facility
Shanghai, 200025, China
Unknown Facility
Donggu, Gwangju Gwang''yeogsi, 501757, South Korea
Unknown Facility
Bucheon-si, Gyeonggido, South Korea
Unknown Facility
Yangsan, Gyeongsangnam-do, South Korea
Unknown Facility
Jongno-gu, South Korea
Unknown Facility
Junggu, South Korea
Unknown Facility
Seoul, 110-744, South Korea
Unknown Facility
Seoul, 120-752, South Korea
Related Publications (1)
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.
PMID: 23134522DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2009
First Posted
October 12, 2009
Study Start
February 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
June 5, 2014
Record last verified: 2014-06