HypertensionPhase 4NCT01071122
FOCUS (Nifedipine GITS's Effect on Central Pressure Assessed by Applanation Tonometry)
A Phase 4 study testing Nifedipine (Adalat, BAYA1040) and Valsartan, Nifedipine (Adalat, BAYA1040) and Valsartan in people with Hypertension, run by Bayer at 15 sites in South Korea.
Trial summary
To determine whether the combination of nifedipine GITS and valsartan is more effective in reducing central blood pressure than nifedipine GITS or valsartan alone, and to determine whether nifedipine GITS is comparable to valsartan Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Nifedipine (Adalat, BAYA1040) and Valsartan, Nifedipine (Adalat, BAYA1040) and Valsartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 15 sitesSouth Korea
- Study dates
- Jan 2010to Feb 2012
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Untreated grade 2 or grade 3 hypertension defined by mean diastolic blood pressure (BP) >/= 100 and/or mean systolic BP >/= 160mmHg without anti-hypertensive treatment or Treated grade 2 hypertension defined by mean diastolic BP >/= 100 and/or mean systolic BP >/=160mmHg with current diuretics and/or beta-blockers use for >/= 4 weeks
Who cannot join
- Secondary form of hypertension
- Mean systolic BP >/= 200mmHg and or mean diastolic BP >/= 120mmHg
- Treated with other antihypertensive medication except diuretics or beta-blockers
- Type 1 diabetes mellitus
- Known cardiovascular disease including history of angina pectoris, heart failure, history of myocardial infarction or revascularization procedure, or cerebrovascular disease (including stroke and transient ischaemic attack) within the previous 12 months
- Renal insufficiency defined as a serum creatinine: >/= 1.7 mg/dl
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- Pregnancy or not using contraceptive in childbearing aged women
- Breast feeding women
- Any disease or condition that in the opinion of the investigator may interfere with completion of the study
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Korea15 sites
Study site
Busan
Study site
Chungchungbuk-do, Korea, 361-711
Study site
Goyang, Gyeonggido, 410-773
Study site
Goyang-si, Gyeonggido, 411-706
Study site
Gwangju, 501-757
Study site
Joong-gu, 100-380
Study site
Kungki-do, 463-707
Study site
Seoul, Korea, 135-720
Study site
Seoul, Seoul Teugbyeolsi, 152-703
Study site
Seoul, 110-744
Study site
Seoul, 120-752
Study site
Seoul, 135-710
Study site
Seoul, 136-705
Study site
Seoul, 137-701
Study site
Suwan, 443-721
About this study
Official title: A Prospective, Open-label, Active-controlled, Randomized Study Comparing Nifedipine GITS Versus Valsartan Versus a Combination of Both on Central Blood Pressure in Inadequately Controlled Essential Hypertension.
To determine whether the combination of nifedipine GITS and valsartan is more effective in reducing central blood pressure than nifedipine GITS or valsartan alone, and to determine whether nifedipine GITS is comparable to valsartan
- Conditions
- Hypertension
- Being tested
- Nifedipine (Adalat, BAYA1040) and Valsartan, Nifedipine (Adalat, BAYA1040), Valsartan
- Keywords
- Central blood pressure, Nifedipine, Valsartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine (Adalat, BAYA1040) and ValsartanDrug
Combination treatment with nifedipine GITS 30mg and valsartan 80mg, Once daily
Nifedipine (Adalat, BAYA1040)Drug
Nifedipine 60mg, Once daily
ValsartanDrug
Valsartan 160mg, Once daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Nifedipine (Adalat, BAYA1040) and Valsartan |
| Arm 2 | Active comparator | Not described Receives: Drug: Nifedipine (Adalat, BAYA1040) |
| Arm 3 | Active comparator | Not described Receives: Drug: Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central systolic blood pressure
Measured: Week 8
Secondary outcomes (7)
Change in central diastolic blood pressure and pulse pressure
Measured: Week 4,8
Change in central systolic blood pressure
Measured: Week 4
Change in brachial systolic blood pressure and diastolic blood pressure
Measured: Week 4,8
Change in brachial pulse pressure
Measured: Week4,8
Change in augmentation index and augmentation pressure
Measured: Week 4,8
Response rate(≥10 mmHg decrease of brachial SBP and ≥5mmHg decrease of brachial DBP)
Measured: Week 4,8
Control rate (≤140/90 mmHg, 130/80 mmHg for diabetes, of brachial BP
Measured: Week 4,8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2012
- Study completionFeb 2012
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
- 365 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
- NCT01071122
- Sponsor's protocol ID
- 14696
- Status last verified
- Jan 2014
- First submitted
- 18 Feb 2010
- Last updated
- 27 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Park JB, Shin JH, Kim DS, Youn HJ, Park SW, Shim WJ, Park CG, Kim DW, Lee HY, Choi DJ, Rim SJ, Lee SY, Kim JH; FOCUS Investigators. Safety of the Up-titration of Nifedipine GITS and Valsartan or Low-dose Combination in Uncontrolled Hypertension: the FOCUS Study. Clin Ther. 2016 Apr;38(4):832-42. doi: 10.1016/j.clinthera.2016.02.025. Epub 2016 Mar 17.
PubMed 26996246
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Active-controlled, Randomized Study Comparing Nifedipine GITS Versus Valsartan Versus a Combination of Both on Central Blood Pressure in Inadequately Controlled Essential Hypertension.
- ClinicalTrials.gov ID
- NCT01071122
- Acronym / sponsor ID
- 14696
- Conditions
- Hypertension
- Keywords
- Central blood pressure, Nifedipine, Valsartan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Feb 2010 (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.
To determine whether the combination of nifedipine GITS and valsartan is more effective in reducing central blood pressure than nifedipine GITS or valsartan alone, and to determine whether nifedipine GITS is comparable to valsartan
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Nifedipine (Adalat, BAYA1040) and Valsartan |
| Arm 2 | Active comparator | Drug: Nifedipine (Adalat, BAYA1040) |
| Arm 3 | Active comparator | Drug: Valsartan |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Untreated grade 2 or grade 3 hypertension defined by mean diastolic blood pressure (BP) >/= 100 and/or mean systolic BP >/= 160mmHg without anti-hypertensive treatment or Treated grade 2 hypertension defined by mean diastolic BP >/= 100 and/or mean systolic BP >/=160mmHg with current diuretics and/or beta-blockers use for >/= 4 weeks
Key exclusion criteria (9 listed)
- Secondary form of hypertension
- Mean systolic BP >/= 200mmHg and or mean diastolic BP >/= 120mmHg
- Treated with other antihypertensive medication except diuretics or beta-blockers
- Type 1 diabetes mellitus
- Known cardiovascular disease including history of angina pectoris, heart failure, history of myocardial infarction or revascularization procedure, or cerebrovascular disease (including stroke and transient ischaemic attack) within the previous 12 months
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 |
|---|---|---|
| Nifedipine (Adalat, BAYA1040) and ValsartanCombination treatment with nifedipine GITS 30mg and valsartan 80mg, Once daily | Drug | Arm 1 |
| Nifedipine (Adalat, BAYA1040)Nifedipine 60mg, Once daily | Drug | Arm 2 |
| ValsartanValsartan 160mg, Once daily | Drug | Arm 3 |
Primary outcome
Central systolic blood pressure
Time frame: Week 8
7 secondary outcomes
Change in central diastolic blood pressure and pulse pressure
Time frame: Week 4,8
Change in central systolic blood pressure
Time frame: Week 4
Change in brachial systolic blood pressure and diastolic blood pressure
Time frame: Week 4,8
Change in brachial pulse pressure
Time frame: Week4,8
Change in augmentation index and augmentation pressure
Time frame: Week 4,8
Response rate(≥10 mmHg decrease of brachial SBP and ≥5mmHg decrease of brachial DBP)
Time frame: Week 4,8
Control rate (≤140/90 mmHg, 130/80 mmHg for diabetes, of brachial BP
Time frame: Week 4,8
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 27 Jan 2014.
- Derived from this study: PubMed 26996246Park JB, Shin JH, Kim DS, Youn HJ, Park SW, Shim WJ, Park CG, Kim DW, Lee HY, Choi DJ, Rim SJ, Lee SY, Kim JH; FOCUS Investigators. Safety of the Up-titration of Nifedipine GITS and Valsartan or Low-dose Combination in Uncontrolled Hypertension: the FOCUS Study. Clin Ther. 2016 Apr;38(4):832-42. doi: 10.1016/j.clinthera.2016.02.025. Epub 2016 Mar 17.
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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
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nifedipine (Adalat, BAYA1040) and Valsartan, Nifedipine (Adalat, BAYA1040) and Valsartan in people with Hypertension, run by Bayer at 15 sites in South Korea.
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 1 inclusion and 9 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 27 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in 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?
Central systolic blood pressure (time frame: Week 8). 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 NCT01071122, 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 27 Jan 2014.