HypertensionPhase 4NCT00993109
Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension
A Phase 4 study testing Adalat (Nifedipine, BAYA1040) and Diovan (Valsartan) in people with Hypertension, run by Bayer at 17 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Adalat (Nifedipine, BAYA1040) and Diovan (Valsartan)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Feb 2010to May 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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 locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
China10 sites
Study site
Beijing, 100029
Study site
Beijing, 100037
Study site
Changsha, Hunan, 410008
Study site
Changsha, Hunan, 410013
Study site
Guangzhou, Guangdong, 510080
Study site
Nanjing, Jiangsu, 210008
Study site
Nanjing, Jiangsu, 210029
Study site
Shanghai, 200025
Study site
Shenyang, Liaoning, 110001
Study site
Shijiazhuang, Hebei, 050051
South Korea7 sites
Study site
Bucheon-si, Gyeonggido
Study site
Donggu, Gwangju Gwang''yeogsi, 501757
Study site
Jongno-gu
Study site
Junggu
Study site
Seoul, 110-744
Study site
Seoul, 120-752
Study site
Yangsan, Gyeongsangnam-do
About this study
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
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.
- Conditions
- Hypertension
- Being tested
- Adalat (Nifedipine, BAYA1040), Diovan (Valsartan)
- Keywords
- Nifedipine GITS/OROS (Adalat®), Valsartan (Diovan®), Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalat (Nifedipine, BAYA1040)Drug
Nifedipine GITS/OROS 30 mg OM + Valsartan 80 mg OM
Diovan (Valsartan)Drug
Valsartan 160 mg OM (Two Valsartan 80mg tablets)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Adalat (Nifedipine, BAYA1040) |
| Arm 2 | Active comparator | Not described Receives: Drug: Diovan (Valsartan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Systolic BP and Diastolic BP on office Blood Pressure monitoring
Measured: Baseline and 12 weeks of treatment
Secondary outcomes (7)
Response rate (>/=10mmHg decrease of office SBP and >/=5mmHg decrease of office DBP)
Measured: 8 and 12 weeks of treatment
Control rate (</=140/90 of office BP)
Measured: 8 and 12 weeks of treatment
Change in pulse pressure (difference between SBP and DBP)
Measured: 12 weeks of treatment
Reduction in Urinary microalbumin excretion(UAE) in patients with microalbuminuria
Measured: Baseline and 12 weeks of treatment
Adverse Event reporting
Measured: At the start, every 4 weeks during treatment and at the end of treatment
Vitals signs
Measured: At the start, every 4 weeks during treatment and at the end of treatment
Laboratory tests
Measured: At the start and at the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startFeb 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993109
- Sponsor's protocol ID
- 14511
- Other IDs
- ADVISE
- Status last verified
- Jun 2014
- First submitted
- 9 Oct 2009
- Last updated
- 5 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23134522
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00993109
- Acronym / sponsor ID
- 14511
- Conditions
- Hypertension
- Keywords
- Nifedipine GITS/OROS (Adalat®), Valsartan (Diovan®), Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 12 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Adalat (Nifedipine, BAYA1040) |
| Arm 2 | Active comparator | Drug: Diovan (Valsartan) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- Participation in any clinical investigational drug study within the previous 12 weeks
- Concomitant treatments with:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adalat (Nifedipine, BAYA1040)Nifedipine GITS/OROS 30 mg OM + Valsartan 80 mg OM | Drug | Arm 1 |
| Diovan (Valsartan)Valsartan 160 mg OM (Two Valsartan 80mg tablets) | Drug | Arm 2 |
Primary outcome
Mean Systolic BP and Diastolic BP on office Blood Pressure monitoring
Time frame: Baseline and 12 weeks of treatment
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2014.
- Derived from this study: PubMed 23134522Ke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalat (Nifedipine, BAYA1040) and Diovan (Valsartan) in people with Hypertension, run by Bayer at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Systolic BP and Diastolic BP on office Blood Pressure monitoring (time frame: Baseline and 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00993109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2014; AzTrials last refreshed its copy on 8 Nov 2026.