HypertensionPhase 4NCT00356395
Safety and Effects of Ramipril Combined With Candesartan
A Phase 4 study testing ramipril, candesartan in people with Hypertension, run by Gachon University Gil Medical Center.
Trial summary
we hypothesized that combination therapy has additive beneficial effects to improve endothelial dysfunction and adipocytokine profiles in patients with hypertension. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- ramipril, candesartan
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Mar 2006
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with mild to moderate hypertension
Who cannot join
- We will exclude patients with severe hypertension, unstable angina, acute myocardial infarction, or renal insufficiency.
About this study
Official title: Cardiovascular and Metabolic Effects of Combination Therapy With Ramipril and Candesartan In Hypertensive Patients
we hypothesized that combination therapy has additive beneficial effects to improve endothelial dysfunction and adipocytokine profiles in patients with hypertension.
Read the detailed description
Forty patients will be given ramipril 10 mg and placebo, ramipril 10 mg and candesartan 16 mg, or candesartan 16 mg and placebo daily in a randomized, double-blind, placebo-controlled cross-over trial with three treatment arms and two washout periods (each 2 months).
- Conditions
- Hypertension
- Being tested
- ramipril, candesartan
- Keywords
- endothelial function, insulin resistance, adipocytokines
- Medical subject headings
- Hypertension, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ramipril, candesartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of endothelium-dependent dilation among the 3 treatment schemes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2006 (estimated)
- Study startAug 2003
- Study completionMar 2006
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.
- 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
- Crossover
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Kwang K Koh, MD, Principal investigator, Cardiology, Gil Heart Center, Gachon Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356395
- Sponsor's protocol ID
- 2003-008
- Status last verified
- Mar 2006
- First submitted
- 25 Jul 2006
- Last updated
- 26 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular and Metabolic Effects of Combination Therapy With Ramipril and Candesartan In Hypertensive Patients
- ClinicalTrials.gov ID
- NCT00356395
- Acronym / sponsor ID
- 2003-008
- Conditions
- Hypertension
- Keywords
- endothelial function, insulin resistance, adipocytokines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Aug 2003
- Study completion
- Mar 2006
- First posted
- 26 Jul 2006 (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.
we hypothesized that combination therapy has additive beneficial effects to improve endothelial dysfunction and adipocytokine profiles in patients with hypertension.
Detailed description
Forty patients will be given ramipril 10 mg and placebo, ramipril 10 mg and candesartan 16 mg, or candesartan 16 mg and placebo daily in a randomized, double-blind, placebo-controlled cross-over trial with three treatment arms and two washout periods (each 2 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with mild to moderate hypertension
Key exclusion criteria (1 listed)
- We will exclude patients with severe hypertension, unstable angina, acute myocardial infarction, or renal insufficiency.
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 |
|---|---|---|
| ramipril, candesartan | Drug | – |
Primary outcome
comparison of endothelium-dependent dilation among the 3 treatment schemes
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 26 Jul 2006.
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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.
Kwang K Koh, MD principal investigator
Cardiology, Gil Heart Center, Gachon Medical School
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ramipril, candesartan in people with Hypertension, run by Gachon University Gil Medical Center.
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 1 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 26 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
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?
comparison of endothelium-dependent dilation among the 3 treatment schemes. 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 26 Jul 2006.