HypertensionPhase 4NCT01819220
Randomized, Open Labeled Clinical Trial to Compare the Effectiveness of Amlodipine/Valsartan vs Hydrochlorothiazide/Telmisartan on Glucose Tolerance in Patients With Hypertension With Metabolic Syndrome
A Phase 4 study testing amlodipine/valsartan and hydrochlorothiazide/telmisartan in people with Hypertension, run by Yonsei University at 1 site in South Korea.
Trial summary
Recent studies have demonstrated that RAS inhibitors/calcium channel blockers are superior to RAS inhibitors/diuretics for reducing cardiovascular outcomes in hypertension. As such, RAS inhibitors/calcium channel blockers are recommended as first line combination treatment for hypertension. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- amlodipine/valsartan and hydrochlorothiazide/telmisartan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2009to Nov 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- consent to the study
- Male or Female ≥ 20 years
- Patients taking less than 1 antihypertensive medications or not taking antihypertensive medications. Hypertension defined at the screening visit as follows): 140mmHg < MSSBP or MSDBP > 90mmHg at screening
- Hypertensive patients with non diabetic metabolic syndrome will be enrolled. Metabolic syndrome is defined according to NCEP guideline. (3 or more than) ① Abdominal obesity: Waist circumference M ≥ 90cm, F ≥ 80cm
- ② Hypertriglyceridaemia: Triglycerides ≥ 150mg/dL
- ③ Low HDL cholesterol Men: HDL cholesterol ≤ 40mg/dL Women: HDL cholesterol ≤ 50mg/dL
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- ④ Elevated blood pressure (systolic blood pressure ≥ 130 mmHg and diastolic blood pressure ≥ 85 mmHg, or current use of antihypertensive drugs)
- ⑤ Impaired fasting glucose: fasting plasma glucose ≥ 100 mg/dL
- Patient not taking statin medication and if the patient had ate statin medication the last duration must be before 3 months.
Who cannot join
- • Women of child-bearing potential without a contraceptive measure
- (Pregnant or nursing women
- Known or suspected contraindications: history of allergy or hypersensitivity
- History of clinically significant allergies including asthma and/or multiple drug allergies
- Patients taking more than 2 antihypertensive medications
- Patient taking statin medication and taking statin within 3 months
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- MSSBP > 180 mmHg or MSDBP > 110 mmHg at any time during the study
- Evidence of a secondary form of hypertension)
- History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, myocardial infarction, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) for 12 months prior to Visit 1
- History of heart failure Grade II - IV according to the NYHA classification
- Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia
- Concomitant unstable angina pectoris
- Clinically significant valvular heart disease
- Patients with Type 1 or Type 2 diabetes mellitus
- Evidence of hepatic disease as determined by one of the following: AST or ALT values ≥ 3 x UNL, a history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt
- Evidence of renal impairment as determined by one of the following: serum creatinine >2mg/dL , history of dialysis, or history of nephrotic syndrome
- Protein in U/A values 2+ ≤
- Serum potassium values < 3.2 or > 5.2 mmol/L
- History of malignancy of any organ system within the past 5 years, treated or untreated, including leukemia and lymphoma, as further defined in the full protocol
- Chronic use of NSAIDs
- Use of cyclooxygenase-2 inhibitors (COX-2 inhibitors
- Use of niacin > 100 mg/d
- Use of loop diuretics
- Use of statin shorter than 3 months
- Inability to discontinue prior antihypertensive drugs as specified in the full protocol
- persons directly involved in the execution of this protocol
- Volume depletion based on the investigator's clinical judgment using vital signs, skin turgor, moistness of mucous membranes, and laboratory values
- Any severe, life-threatening disease within the past five years
Trial locations and contacts
1 site in 1 country.
About this study
Recent studies have demonstrated that RAS inhibitors/calcium channel blockers are superior to RAS inhibitors/diuretics for reducing cardiovascular outcomes in hypertension. As such, RAS inhibitors/calcium channel blockers are recommended as first line combination treatment for hypertension. However, the mechanism for the superior efficacy of RAS inhibitors/calcium channel blockers are not well defined. This study will compare the efficacy of RAS inhibitors/calcium channel blockers vs RAS inhibitors/diuretics in terms of glucose tolerance and insulin resistance in hypertensive patients with metabolic syndrome. The primary endpoint will be that RAS inhibitors/calcium channel blockers will be more efficacious in reducing 2hour post prandial glucose compared to RAS inhibitors/diuretics.
- Conditions
- Hypertension
- Being tested
- amlodipine/valsartan, hydrochlorothiazide/telmisartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amlodipine/valsartanDrug
Also called Starting dose of amlodipine 5mg/ valsartan 80mg
This is a phase IV clinical study. The study is a 24 week, prospective, randomized open labeled multicenter study to compare the efficacy of amlodipine/valsartan combination vs telmisartan/hydrochlorothiazide combination in reducing post prandial sugar. The study will be performed in hypertensive patients with metabolic syndrome.
Active group: Starting dose of amlodipine 5mg/ valsartan 80mg comparator group: Telmisartan 40mg/hydrochlorothiazide 12.5mg When the blood pressure is above the target goal of 140/90mmHg, up titration to amlodipine 5/valsartan 160 and/or telmisartan 80/hydrochlorothiazide 12.5mg is allowed.
When the blood pressure is above 140/90mmhg at the 12th week, addition of doxazosin 4mg is allowed.
hydrochlorothiazide/telmisartanDrug
Also called Telmisartan 40mg/hydrochlorothiazide 12.5mg
When the blood pressure is above the target goal of 140/90mmHg, uptitration to amlodipine 5/valsartan 160 and/or telmisartan 80/hydrochlorothiazide 12.5mg is allowed.
When the blood pressure is above 140/90mmhg at the 12th week, addition of doxazosin 4mg is allowed.
| Study group | Role | What they receive |
|---|---|---|
| amlodipine/valsartan | Active comparator | Not described Receives: Drug: amlodipine/valsartan |
| hydrochlorothiazide/telmisartan | Experimental | Not described Receives: Drug: hydrochlorothiazide/telmisartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the glucose change
Measured: To assess the change from baseline (week 0) to study endpoint (week 24) on 2hr-post-prandial plasma glucose level using oral glucose tolerance test (75-g OGTT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startApr 2009
- Primary completionNov 2014
- Study completionNov 2014
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
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819220
- Sponsor's protocol ID
- 4-2009-0077
- Status last verified
- Jun 2015
- First submitted
- 15 Mar 2013
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Labeled Clinical Trial to Compare the Effectiveness of Amlodipine/Valsartan vs Hydrochlorothiazide/Telmisartan on Glucose Tolerance in Patients With Hypertension With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01819220
- Acronym / sponsor ID
- 4-2009-0077
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 27 Mar 2013 (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.
Recent studies have demonstrated that RAS inhibitors/calcium channel blockers are superior to RAS inhibitors/diuretics for reducing cardiovascular outcomes in hypertension. As such, RAS inhibitors/calcium channel blockers are recommended as first line combination treatment for hypertension. However, the mechanism for the superior efficacy of RAS inhibitors/calcium channel blockers are not well defined. This study will compare the efficacy of RAS inhibitors/calcium channel blockers vs RAS inhibitors/diuretics in terms of glucose tolerance and insulin resistance in hypertensive patients with metabolic syndrome. The primary endpoint will be that RAS inhibitors/calcium channel blockers will be more efficacious in reducing 2hour post prandial glucose compared to RAS inhibitors/diuretics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amlodipine/valsartan | Active comparator | Drug: amlodipine/valsartan |
| hydrochlorothiazide/telmisartan | Experimental | Drug: hydrochlorothiazide/telmisartan |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- consent to the study
- Male or Female ≥ 20 years
- Patients taking less than 1 antihypertensive medications or not taking antihypertensive medications. Hypertension defined at the screening visit as follows): 140mmHg < MSSBP or MSDBP > 90mmHg at screening
- Hypertensive patients with non diabetic metabolic syndrome will be enrolled. Metabolic syndrome is defined according to NCEP guideline. (3 or more than) ① Abdominal obesity: Waist circumference M ≥ 90cm, F ≥ 80cm
- ② Hypertriglyceridaemia: Triglycerides ≥ 150mg/dL
Key exclusion criteria (28 listed)
- • Women of child-bearing potential without a contraceptive measure
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 |
|---|---|---|
| amlodipine/valsartanAlso: Starting dose of amlodipine 5mg/ valsartan 80mgThis is a phase IV clinical study. The study is a 24 week, prospective, randomized open labeled multicenter study to compare the efficacy of amlodipine/valsartan combination vs telmisartan/hydrochlorothiazide combination in reducing post prandial sugar. The study will be performed in hypertensive patients with metabolic syndrome. Active group: Starting dose of amlodipine 5mg/ valsartan 80mg comparator group: Telmisartan 40mg/hydrochlorothiazide 12.5mg When the blood pressure is above the target goal of 140/90mmHg, up titration to amlodipine 5/valsartan 160 and/or telmisartan 80/hydrochlorothiazide 12.5mg is allowed. When the blood pressure is above 140/90mmhg at the 12th week, addition of doxazosin 4mg is allowed. | Drug | amlodipine/valsartan |
| hydrochlorothiazide/telmisartanAlso: Telmisartan 40mg/hydrochlorothiazide 12.5mgWhen the blood pressure is above the target goal of 140/90mmHg, uptitration to amlodipine 5/valsartan 160 and/or telmisartan 80/hydrochlorothiazide 12.5mg is allowed. When the blood pressure is above 140/90mmhg at the 12th week, addition of doxazosin 4mg is allowed. | Drug | hydrochlorothiazide/telmisartan |
Primary outcome
To assess the glucose change
Time frame: To assess the change from baseline (week 0) to study endpoint (week 24) on 2hr-post-prandial plasma glucose level using oral glucose tolerance test (75-g OGTT)
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 10 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 amlodipine/valsartan and hydrochlorothiazide/telmisartan 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 9 inclusion and 28 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 10 Jun 2015. 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. 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?
To assess the glucose change (time frame: To assess the change from baseline (week 0) to study endpoint (week 24) on 2hr-post-prandial plasma glucose level using oral glucose tolerance test (75-g OGTT)). 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 10 Jun 2015.