HypertensionPhase 4NCT01091753
Effect of Nocturnal Administration of Anti-hypertensive Medications in NoN-dippers
A Phase 4 study testing Valsaltan, amlodipine in people with Hypertension, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the effect of nocturnal administration of Anti-hypertensive medications in Non-dippers. Efficacy variables. 1. ECHO 2. 24hr. horter 3. IMT 4. BUN/crea, urine analysis (microalbulinuria 5. Cardio vascular event. " Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Valsaltan, amlodipine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2008to Sep 2009
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Essential hypertension (stage 1-2)
- 24hr. holer : non-dipper
- Age 18 ~70.
Who cannot join
- Any known malignant disease
- Renal failure , creatinine >2.0mg/dl
- Liver disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University College of Medicine
Seoul
About this study
The purpose of this study is to determine the effect of nocturnal administration of Anti-hypertensive medications in Non-dippers.
Efficacy variables.
- ECHO
- 24hr. horter
- IMT
- BUN/crea, urine analysis (microalbulinuria
- Cardio vascular event. "
- Conditions
- Hypertension
- Being tested
- Valsaltan, amlodipine
- Keywords
- Non-dipper HTN patient
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsaltan, amlodipineDrug
nti hypertensive medication time (nocturnal administration vs morning administration
| Study group | Role | What they receive |
|---|---|---|
| morning administration group | Placebo comparator | Not described Receives: Drug: Valsaltan, amlodipine |
| nocturnal administration group | Experimental | Not described Receives: Drug: Valsaltan, amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMT(intima media thickness) Measure data(Sono)
Measured: baseline
IMT(intima media thickness) Measure data(Sono)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMar 2008
- Primary completionMay 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Dong hun Choi, Principal investigator, professor of division of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091753
- Sponsor's protocol ID
- 4-2007-0440
- Status last verified
- Oct 2010
- First submitted
- 23 Mar 2010
- Last updated
- 8 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nocturnal Administration of Anti-hypertensive Medications in NoN-dippers
- ClinicalTrials.gov ID
- NCT01091753
- Acronym / sponsor ID
- 4-2007-0440
- Conditions
- Hypertension
- Keywords
- Non-dipper HTN patient
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 24 Mar 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.
The purpose of this study is to determine the effect of nocturnal administration of Anti-hypertensive medications in Non-dippers.
Efficacy variables.
- ECHO
- 24hr. horter
- IMT
- BUN/crea, urine analysis (microalbulinuria
- Cardio vascular event. "
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| morning administration group | Placebo comparator | Drug: Valsaltan, amlodipine |
| nocturnal administration group | Experimental | Drug: Valsaltan, amlodipine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Essential hypertension (stage 1-2)
- 24hr. holer : non-dipper
- Age 18 ~70.
Key exclusion criteria (3 listed)
- Any known malignant disease
- Renal failure , creatinine >2.0mg/dl
- Liver disease
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 |
|---|---|---|
| Valsaltan, amlodipinenti hypertensive medication time (nocturnal administration vs morning administration | Drug | morning administration group, nocturnal administration group |
Primary outcome
IMT(intima media thickness) Measure data(Sono)
Time frame: baseline
IMT(intima media thickness) Measure data(Sono)
Time frame: 36 months
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 8 Oct 2010.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Dong hun Choi principal investigator
professor of division of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valsaltan, amlodipine in people with Hypertension, run by Yonsei University at 1 site 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 3 inclusion and 3 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 8 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
IMT(intima media thickness) Measure data(Sono) (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2010; AzTrials last refreshed its copy on 8 Nov 2026.