HypertensionPhase 4HOT-DMNCT00847262
Trial Comparing Metabolic Effects of Telmisartan and Amlodipine on Hypertensive Patients With Obesity and Diabetes
A Phase 4 study testing Temisartan and Amlodipine in people with Hypertension and Obesity, run by Third Military Medical University at 1 site in China.
Trial summary
Recent studies have shown that obese people are more prone to high blood pressure. With the co-existence of obesity, hypertension and diabetes, patients were more susceptible to hyperlipidemia, coronary and cerebral atherosclerosis and peripheral vascular disease. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Hypertension, Obesity, Diabetes
- What is being tested?
- Temisartan and Amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jun 2008to Jun 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Information Consent Signed
- Aged 30~70 years
- For whom without anti-hypertensive therapy in 2 weeks：140mmHg≤SBP<180mmHg，或90mmHg≤DBP<110mmHg. For whom with anti-hypertensive therapies in 2 weeks：SBP<180mmHg, 且DBP<110mmHg
- Waist circumference higher than 90cm in men, 80cm in women
- Diagnosed diabetes
Who cannot join
- Grade 3 hypertension: SBP≥180mmHg, or DBP≥110mmHg
- Waist circumference less than 90cm in men, 80cm in women
- Known allergy or hypersensitivity to trial drugs
- NYHA grade Ⅱ~Ⅳ heart failure, Myocardial infarction or cerebrovascular accident in 1 year preceding the trial
- Acute infections, tumor, severe arrhythmia, mental disease, drug or alcohol abuse
- History of hepatitis or cirrhosis
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- History of severe kidney disease
- Pregnant, lactation
- Enrolled in other trials in 3 months
- Any obstacles of follow-up or compliance
Trial locations and contacts
1 site in 1 country.
China1 site
The third hospital affiliated to the Third Military Medical University
Chongqing, 400042
About this study
Official title: Hypertension With Obesity Trial: Diabetes Mellitus Branch
Recent studies have shown that obese people are more prone to high blood pressure. With the co-existence of obesity, hypertension and diabetes, patients were more susceptible to hyperlipidemia, coronary and cerebral atherosclerosis and peripheral vascular disease. Abdominal obesity has often accompanied by substantial accumulation of visceral fat, which increased secretion of many inflammatory mediators, cytokines and adipocytokines and played an important role in cardiovascular and metabolic disease. Some reports had shown that angiotensin II receptor blockers (ARB) may improve metabolic profiles in patients with diabetes or metabolic syndrome, in addition to its hypotensive effect. It has been reported that some ARB, such as telmisartan and candesartan, can prevent weight gain and high-fat-induced obesity in experimental animals. However, whether telmisartan intervention on improvement of fat deposition and other related metabolic profiles is better than a CCB drugs (amlodipine) in those obese hypertensive patients with diabetes, was still unknown.
- Conditions
- Hypertension, Obesity, Diabetes
- Being tested
- Temisartan, Amlodipine
- Keywords
- Hypertension, Abdominal obesity, Diabetes, Treatment
- Medical subject headings
- Hypertension, Obesity, Diabetes Mellitus, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemisartanDrug
Temisartan, initial dose: 40 mg per day, Max dose: 160 mg per day
AmlodipineDrug
Amlodipine, initial dose: 5 mg per day, Max dose: 10 mg per day
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan Group | Experimental | Telmisartan intervention group Receives: Drug: Temisartan |
| Amlodipine Group | Active comparator | Amlodipine intervention group Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Measured: Baseline, 24 weeks(End of trial)
Metabolic profiles, including lipid profile and blood glucose
Measured: Baseline, 24 weeks(End of trial)
Secondary outcomes (3)
Abdominal fat assessed by CT
Measured: Baseline, 24 weeks(End of trial)
Obesity parameters, including waist circumference (WC) and body mass index (BMI)
Measured: Baseline, 24 weeks(End of trial)
Incidents of side effects between groups
Measured: Baseline, 24 weeks(End of trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startJun 2008
- Primary completionDec 2008
- Study completionJun 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.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiming Zhu, Third Military Medical University
- Investigators
- Zhiming Zhu, MD, PhD, Principal investigator, The third hospital affiliated to the Third Military Medical University. China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847262
- Sponsor's protocol ID
- HOT-2
- Acronym
- HOT-DM
- Status last verified
- Dec 2013
- First submitted
- 17 Feb 2009
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension With Obesity Trial: Diabetes Mellitus Branch
- ClinicalTrials.gov ID
- NCT00847262
- Acronym / sponsor ID
- HOT-DM / HOT-2
- Conditions
- Hypertension, Obesity, Diabetes
- Keywords
- Hypertension, Abdominal obesity, Diabetes, Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 19 Feb 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.
Recent studies have shown that obese people are more prone to high blood pressure. With the co-existence of obesity, hypertension and diabetes, patients were more susceptible to hyperlipidemia, coronary and cerebral atherosclerosis and peripheral vascular disease. Abdominal obesity has often accompanied by substantial accumulation of visceral fat, which increased secretion of many inflammatory mediators, cytokines and adipocytokines and played an important role in cardiovascular and metabolic disease. Some reports had shown that angiotensin II receptor blockers (ARB) may improve metabolic profiles in patients with diabetes or metabolic syndrome, in addition to its hypotensive effect. It has been reported that some ARB, such as telmisartan and candesartan, can prevent weight gain and high-fat-induced obesity in experimental animals. However, whether telmisartan intervention on improvement of fat deposition and other related metabolic profiles is better than a CCB drugs (amlodipine) in those obese hypertensive patients with diabetes, was still unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan Group | Experimental | Drug: TemisartanTelmisartan intervention group |
| Amlodipine Group | Active comparator | Drug: AmlodipineAmlodipine intervention group |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Information Consent Signed
- Aged 30~70 years
- For whom without anti-hypertensive therapy in 2 weeks：140mmHg≤SBP<180mmHg，或90mmHg≤DBP<110mmHg. For whom with anti-hypertensive therapies in 2 weeks：SBP<180mmHg, 且DBP<110mmHg
- Waist circumference higher than 90cm in men, 80cm in women
- Diagnosed diabetes
Key exclusion criteria (10 listed)
- Grade 3 hypertension: SBP≥180mmHg, or DBP≥110mmHg
- Waist circumference less than 90cm in men, 80cm in women
- Known allergy or hypersensitivity to trial drugs
- NYHA grade Ⅱ~Ⅳ heart failure, Myocardial infarction or cerebrovascular accident in 1 year preceding the trial
- Acute infections, tumor, severe arrhythmia, mental disease, drug or alcohol abuse
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 |
|---|---|---|
| TemisartanTemisartan, initial dose: 40 mg per day, Max dose: 160 mg per day | Drug | Telmisartan Group |
| AmlodipineAmlodipine, initial dose: 5 mg per day, Max dose: 10 mg per day | Drug | Amlodipine Group |
Primary outcome
Blood Pressure
Time frame: Baseline, 24 weeks(End of trial)
Metabolic profiles, including lipid profile and blood glucose
Time frame: Baseline, 24 weeks(End of trial)
3 secondary outcomes
Abdominal fat assessed by CT
Time frame: Baseline, 24 weeks(End of trial)
Obesity parameters, including waist circumference (WC) and body mass index (BMI)
Time frame: Baseline, 24 weeks(End of trial)
Incidents of side effects between groups
Time frame: Baseline, 24 weeks(End of trial)
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 17 Dec 2013.
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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.
Zhiming Zhu, MD, PhD principal investigator
The third hospital affiliated to the Third Military Medical University. China
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 Temisartan and Amlodipine in people with Hypertension and Obesity, run by Third Military Medical University at 1 site in China.
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 5 inclusion and 10 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 17 Dec 2013. 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 China. 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?
Blood Pressure (time frame: Baseline, 24 weeks(End of trial)). 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 17 Dec 2013.