HypertensionPhase 4TARGETNCT01138423
Treatment of Adiposity Related hypErTension (TARGET)
A Phase 4 study testing Aliskiren, Moxonidine and Hydrochlorothiazide in people with Hypertension and Abdominal Obesity, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
High blood pressure (hypertension) is an important cause of myocardial infarction and stroke. High blood pressure often occurs in people who are overweight. These people frequently also have abnormal fat and sugar metabolism. The combination of these problems is called the 'metabolic syndrome'. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Hypertension, Abdominal Obesity, Metabolic Syndrome
- What is being tested?
- Aliskiren, Moxonidine and Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is a male or post menopausal female, 30-70 years of age on the day of signing informed consent. Post menopausal status is assumed if a woman has not experienced a menstrual bleed for a minimum of 12 months, assuming that she still has a uterus, and is not pregnant or lactating. In women without a uterus, menopause or postmenopause is defined by a very high FSH level.
- All patients should fulfil the diagnostic criterion of abdominal adiposity: waist circumference > 102 cm (men) or > 88 cm (women). The waist circumference is measured halfway between the lower rib and iliac crest in standing position.
- All patients should fulfil the diagnostic criterium for hypertension: systolic blood pressure >/= 130 mmHg and/or diastolic blood pressure >/= 85 mmHg during both visits. Blood pressure is assessed by office readings in accordance with current guidelines for hypertension diagnosis. The patient needs to be seated some minutes before and during the measurement. The cuff size should be adjusted to the patients' arm circumference and needs to be on the same height level as the patients' sternum during the measurements. Blood pressure is determined to a 2 mmHg accuracy-level. Blood pressure is measured on both arms during the first visit. In both measurements differ more than 10 mmHg, the highest value is taken. After at least 15 seconds, the measurement is repeated during the same visit. The highest mean of the two measurements on the same arm is considered as the actual blood pressure value.
- Patients should fulfil one or more of the following criteria to meet the definition of the metabolic syndrome: 1)Hypertriglyceridemia (serum triglycerides > 1.7 mmol/L); 2) Low High-density lipoprotein (HDL)-cholesterol (serum HDL-cholesterol < 1.04 mmol/L (men) or < 1.29 mmol/L (women)); 3)High fasting glucose (fasting serum glucose > 5.6 mmol/L).
- Patient understands the study procedures, alternative treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.
Who cannot join
- Systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg during one or more screening measurements.
- Body Mass Index (BMI) > 35 kg/m2
- Current smoking or smoking during the previous 3 months
- Use of "recreational" or illicit drugs
- Recent history (within the last year) of alcohol abuse or dependence.
- History of hypersensitivity reactions or intolerance to any (components of) medication used in this trial.
Show all 10Show fewer
- Current / recent participation (within 30 days of signing informed consent) in a study with an investigational compound or device.
- Laboratory values as follows: Hemoglobin (Hb) < 8,6 mmol/L (men) or < 7.4 mmol/L (women); TSH <0.3 mcIU/mL or > 5.0 mcIU/mL; Potassium < 3,8 mmol/L or > 5,0 mmol/L; Sodium < 136 mmol/L or > 146 mmol/L; MDRD < 60 mL/min/1,73m2
- Medical conditions as follows: Resistant hypertension (blood pressure above target level, despite 3 antihypertensives, including a diuretic); Secondary hypertension; Congestive Heart Failure; Atherosclerotic vascular disease (As per NCEP ATP III and AHA/ACC Guidelines); Cardiac arrhythmia's, for example bradycardia, atrial fibrillation, sick-sinus syndrome, sinoatrial block, atrioventricular block or any other arrhythmia; Obstructive sleep apnea syndrome (OSAS) or a score of 10 or higher on the Epworth Sleepiness Scale questionnaire; Serious liver function disorders (Child-Pugh-Class C); COPD (GOLD classification of severity 2 or higher); Celiac disease or other significant intestinal malabsorption; Malignancy ≤ 5 years prior to signing informed consent, except for adequately treated basal or squamous cell skin cancer or in situ cervical cancer; Mental instability or major psychiatric illness; Polyneuropathy or clinical suspicion for autonomic nervous system dysfunction; Any diseases that would limit or complicate study evaluation or participation; Any diseases or screening abnormalities that call for treatment that can not be postponed until after the study period without causing harm.
- Any concomitant medication, particularly antihypertensive co-medication, glucose lowering medication, lipid lowering drugs, systemic corticosteroids, birth control pills and vitamin C or E supplements, but also any other kinds of drugs, including over the counter medication. Exceptions can be made for the following categories of drugs: paracetamol; proton-pump inhibitors; topical creams and unguents that do not lead to uptake of any of the active components into the circulation (in case of steroid creams: class II or lower); inhalation medication, nasal sprays and eye drops that do not lead to uptake of any of the active components into the circulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-controlled, Double Blind, 4-period, Cross-over Trial, to Study the Effects of Aliskiren, Hydrochlorothiazide and Moxonidine on Endothelial Dysfunction in Obesity Related Hypertension
High blood pressure (hypertension) is an important cause of myocardial infarction and stroke. High blood pressure often occurs in people who are overweight. These people frequently also have abnormal fat and sugar metabolism. The combination of these problems is called the 'metabolic syndrome'.
People with hypertension and obesity currently receive the same drug therapy as people with hypertension, but without obesity. Different classes of drugs are thought to be equally effective in lowering blood pressure.
Read more
Next to lowering blood pressure, hypertension treatment can have additional effects, like changes in blood vessel function (the ability to dilate and constrict) or changes is the metabolism of sugar and fat. Particularly in patients with the metabolic syndrome, these additional effects are thought to be of great importance, because they can influence the risk for cardiovascular diseases.
The blood pressure lowering mechanism differs between classes of blood pressure lowering medication. The purpose of this study is to compare the effects of three types of blood pressure lowering medication belonging to different classes. The main outcomes of interest will be blood vessel function (the ability to dilate and constrict) and blood pressure. Moreover, the effect of treatment on additional outcomes, like metabolism of sugar and fat, will be studied.
Read the detailed description
Treatment of obesity related hypertension (ORH) is challenging and has become an important global health problem. According to guidelines, most classes of antihypertensives are equally effective for the treatment of hypertension. However, these guidelines are based on evidence from studies in patients with essential hypertension, but without a specific focus on ORH. There is an increasing body of evidence about the complex pathophysiological mechanisms of ORH. Adipose tissue dysfunction is commonly regarded as a common soil that eventually causes up regulation of the sympathetic nervous system (SNS) and the renin-angiotensin-system (RAS). Moreover, development of hypertension is closely related to development of endothelial dysfunction, dyslipidemia and disorders of glucose metabolism. The investigators hypothesize that treatment with antihypertensives that are directed at down regulation of the SNS (moxonidine) and the RAS (aliskiren) will result in more beneficial effects than treatment with a diuretic (hydrochlorothiazide), because the latter reduces blood pressure by inhibition of sodium resorption, without influencing the underlying disease mechanism. The main outcomes of interest are endothelial function and blood pressure, but many secondary outcomes are studied too.
- Conditions
- Hypertension, Abdominal Obesity, Metabolic Syndrome
- Being tested
- Aliskiren, Moxonidine, Hydrochlorothiazide, Placebo (for aliskiren), Placebo (for moxonidine and hydrochlorothiazide)
- Keywords
- Hypertension, Metabolic Syndrome X, Obesity, Adiposity, Clinical trial
- Medical subject headings
- Hypertension, Obesity, Abdominal, Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
Also called Brand name: Ralisez, ATC-code: C09XA02
Once daily treatment with aliskiren for 8-weeks, according to the following regiment: once daily (morning time) 150 mg during the first 2 weeks, followed by once daily (morning time) 300 mg during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 150 mg on day 1, 2, 3, 4, 5 and 7.
MoxonidineDrug
Also called No brand name (generic product), ATC-code: C02AC05
Once daily treatment with moxonidine for 8-weeks, according to the following regiment: once daily (morning time) 0.2 mg during the first 2 weeks, followed by once daily (morning time) 0.4 mg during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 0.2 mg on day 1, 2, 3, 4, 5 and 7.
HydrochlorothiazideDrug
Also called No brand name (generic product), ATC-code: C03AA03
Once daily treatment with hydrochlorothiazide for 8-weeks, according to the following regiment: once daily (morning time) 12.5 mg during the first 2 weeks, followed by once daily (morning time) 25 mg during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 12.5 mg on day 1, 2, 3, 4, 5 and 7.
Placebo (for aliskiren)Drug
Once daily treatment with placebo tablets for 8-weeks, according to the following regiment: once daily (morning time) 1 tablet during the first 2 weeks, followed by once daily (morning time) 2 tablets during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 1 tablet on day 1, 2, 3, 4, 5 and 7.
Placebo (for moxonidine and hydrochlorothiazide)Drug
Once daily treatment with placebo capsules for 8-weeks, according to the following regiment: once daily (morning time) 1 capsule during the first 2 weeks, followed by once daily (morning time) 2 capsules during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 1 tablet on day 1, 2, 3, 4, 5 and 7.
| Study group | Role | What they receive |
|---|---|---|
| Aliskiren | Experimental | Not described Receives: Drug: Aliskiren; Drug: Placebo (for moxonidine and hydrochlorothiazide) |
| Moxonidine | Experimental | Not described Receives: Drug: Moxonidine; Drug: Placebo (for aliskiren) |
| Hydrochlorothiazide | Experimental | Not described Receives: Drug: Hydrochlorothiazide; Drug: Placebo (for aliskiren) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo (for aliskiren); Drug: Placebo (for moxonidine and hydrochlorothiazide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function assessed by Flow Mediated Dilation (FMD)
Measured: After 8 weeks treatment
Secondary outcomes (11)
Mean 24-hour systolic/diastolic blood pressure Mean day- and night time systolic/diastolic blood pressure
Measured: After 8 weeks treatment
Central Blood pressure (estimated with pulse wave analysis)
Measured: After 8 weeks treatment
Renin-Angiotensin System (RAS) hormone concentrations
Measured: After 8 weeks treatment
Sympathetic nervous system activity, assessed by Muscle Sympathetic Nerve Activity (MSNA) and Heart Rate Variability (HRV)
Measured: After 8 weeks treatment
Markers of oxidative stress (concentrations of F2-isoprostanes in urine and oxLDL in plasma)
Measured: After 8 weeks treatment
Markers of inflammation (hs-CRP in plasma)
Measured: After 8 weeks treatment
Fractional sodium excretion
Measured: After 8 weeks treatment
Arterial stiffness (assessed by pulse wave velocity and the pulse wave analysis augmentation index)
Measured: After 8 weeks treatment
Adipose tissue function (serum concentrations of adipokines)
Measured: After 8 weeks treatment
Lipid metabolism (serum lipid concentrations)
Measured: After 8 weeks treatment
Insulin sensitivity, expressed by homeostatic model assessment (HOMA)
Measured: After 8 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startAug 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 UMC UtrechtThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Investigators
- F.L.J. Visseren, Professor (MD PhD), Study chair, UMC UtrechtW. Spiering, MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138423
- Sponsor's protocol ID
- UMCU-Vasc-14A
- Acronym
- TARGET
- Status last verified
- Feb 2012
- First submitted
- 4 Jun 2010
- Last updated
- 24 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Schrover IM, Dorresteijn JAN, Smits JE, Danser AHJ, Visseren FLJ, Spiering W. Identifying treatment response to antihypertensives in patients with obesity-related hypertension. Clin Hypertens. 2017 Oct 24;23:20. doi: 10.1186/s40885-017-0077-x. eCollection 2017.
PubMed 29085669
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double Blind, 4-period, Cross-over Trial, to Study the Effects of Aliskiren, Hydrochlorothiazide and Moxonidine on Endothelial Dysfunction in Obesity Related Hypertension
- ClinicalTrials.gov ID
- NCT01138423
- Acronym / sponsor ID
- TARGET / UMCU-Vasc-14A
- Conditions
- Hypertension, Abdominal Obesity, Metabolic Syndrome
- Keywords
- Hypertension, Metabolic Syndrome X, Obesity, Adiposity, Clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Aug 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 Jun 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.
High blood pressure (hypertension) is an important cause of myocardial infarction and stroke. High blood pressure often occurs in people who are overweight. These people frequently also have abnormal fat and sugar metabolism. The combination of these problems is called the 'metabolic syndrome'.
People with hypertension and obesity currently receive the same drug therapy as people with hypertension, but without obesity. Different classes of drugs are thought to be equally effective in lowering blood pressure.
Next to lowering blood pressure, hypertension treatment can have additional effects, like changes in blood vessel function (the ability to dilate and constrict) or changes is the metabolism of sugar and fat. Particularly in patients with the metabolic syndrome, these additional effects are thought to be of great importance, because they can influence the risk for cardiovascular diseases.
The blood pressure lowering mechanism differs between classes of blood pressure lowering medication. The purpose of this study is to compare the effects of three types of blood pressure lowering medication belonging to different classes. The main outcomes of interest will be blood vessel function (the ability to dilate and constrict) and blood pressure. Moreover, the effect of treatment on additional outcomes, like metabolism of sugar and fat, will be studied.
Detailed description
Treatment of obesity related hypertension (ORH) is challenging and has become an important global health problem. According to guidelines, most classes of antihypertensives are equally effective for the treatment of hypertension. However, these guidelines are based on evidence from studies in patients with essential hypertension, but without a specific focus on ORH. There is an increasing body of evidence about the complex pathophysiological mechanisms of ORH. Adipose tissue dysfunction is commonly regarded as a common soil that eventually causes up regulation of the sympathetic nervous system (SNS) and the renin-angiotensin-system (RAS). Moreover, development of hypertension is closely related to development of endothelial dysfunction, dyslipidemia and disorders of glucose metabolism. The investigators hypothesize that treatment with antihypertensives that are directed at down regulation of the SNS (moxonidine) and the RAS (aliskiren) will result in more beneficial effects than treatment with a diuretic (hydrochlorothiazide), because the latter reduces blood pressure by inhibition of sodium resorption, without influencing the underlying disease mechanism. The main outcomes of interest are endothelial function and blood pressure, but many secondary outcomes are studied too.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aliskiren | Experimental | Drug: Aliskiren, Drug: Placebo (for moxonidine and hydrochlorothiazide) |
| Moxonidine | Experimental | Drug: Moxonidine, Drug: Placebo (for aliskiren) |
| Hydrochlorothiazide | Experimental | Drug: Hydrochlorothiazide, Drug: Placebo (for aliskiren) |
| Placebo | Placebo comparator | Drug: Placebo (for aliskiren), Drug: Placebo (for moxonidine and hydrochlorothiazide) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is a male or post menopausal female, 30-70 years of age on the day of signing informed consent. Post menopausal status is assumed if a woman has not experienced a menstrual bleed for a minimum of 12 months, assuming that she still has a uterus, and is not pregnant or lactating. In women without a uterus, menopause or postmenopause is defined by a very high FSH level.
- All patients should fulfil the diagnostic criterion of abdominal adiposity: waist circumference > 102 cm (men) or > 88 cm (women). The waist circumference is measured halfway between the lower rib and iliac crest in standing position.
- All patients should fulfil the diagnostic criterium for hypertension: systolic blood pressure >/= 130 mmHg and/or diastolic blood pressure >/= 85 mmHg during both visits. Blood pressure is assessed by office readings in accordance with current guidelines for hypertension diagnosis. The patient needs to be seated some minutes before and during the measurement. The cuff size should be adjusted to the patients' arm circumference and needs to be on the same height level as the patients' sternum during the measurements. Blood pressure is determined to a 2 mmHg accuracy-level. Blood pressure is measured on both arms during the first visit. In both measurements differ more than 10 mmHg, the highest value is taken. After at least 15 seconds, the measurement is repeated during the same visit. The highest mean of the two measurements on the same arm is considered as the actual blood pressure value.
- Patients should fulfil one or more of the following criteria to meet the definition of the metabolic syndrome: 1)Hypertriglyceridemia (serum triglycerides > 1.7 mmol/L); 2) Low High-density lipoprotein (HDL)-cholesterol (serum HDL-cholesterol < 1.04 mmol/L (men) or < 1.29 mmol/L (women)); 3)High fasting glucose (fasting serum glucose > 5.6 mmol/L).
- Patient understands the study procedures, alternative treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.
Key exclusion criteria (10 listed)
- Systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg during one or more screening measurements.
- Body Mass Index (BMI) > 35 kg/m2
- Current smoking or smoking during the previous 3 months
- Use of "recreational" or illicit drugs
- Recent history (within the last year) of alcohol abuse or dependence.
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 |
|---|---|---|
| AliskirenAlso: Brand name: Ralisez, ATC-code: C09XA02Once daily treatment with aliskiren for 8-weeks, according to the following regiment: once daily (morning time) 150 mg during the first 2 weeks, followed by once daily (morning time) 300 mg during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 150 mg on day 1, 2, 3, 4, 5 and 7. | Drug | Aliskiren |
| MoxonidineAlso: No brand name (generic product), ATC-code: C02AC05Once daily treatment with moxonidine for 8-weeks, according to the following regiment: once daily (morning time) 0.2 mg during the first 2 weeks, followed by once daily (morning time) 0.4 mg during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 0.2 mg on day 1, 2, 3, 4, 5 and 7. | Drug | Moxonidine |
| HydrochlorothiazideAlso: No brand name (generic product), ATC-code: C03AA03Once daily treatment with hydrochlorothiazide for 8-weeks, according to the following regiment: once daily (morning time) 12.5 mg during the first 2 weeks, followed by once daily (morning time) 25 mg during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 12.5 mg on day 1, 2, 3, 4, 5 and 7. | Drug | Hydrochlorothiazide |
| Placebo (for aliskiren)Once daily treatment with placebo tablets for 8-weeks, according to the following regiment: once daily (morning time) 1 tablet during the first 2 weeks, followed by once daily (morning time) 2 tablets during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 1 tablet on day 1, 2, 3, 4, 5 and 7. | Drug | Hydrochlorothiazide, Moxonidine, Placebo |
| Placebo (for moxonidine and hydrochlorothiazide)Once daily treatment with placebo capsules for 8-weeks, according to the following regiment: once daily (morning time) 1 capsule during the first 2 weeks, followed by once daily (morning time) 2 capsules during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 1 tablet on day 1, 2, 3, 4, 5 and 7. | Drug | Aliskiren, Placebo |
Primary outcome
Endothelial function assessed by Flow Mediated Dilation (FMD)
Time frame: After 8 weeks treatment
11 secondary outcomes
Mean 24-hour systolic/diastolic blood pressure Mean day- and night time systolic/diastolic blood pressure
Time frame: After 8 weeks treatment
Central Blood pressure (estimated with pulse wave analysis)
Time frame: After 8 weeks treatment
Renin-Angiotensin System (RAS) hormone concentrations
Time frame: After 8 weeks treatment
Sympathetic nervous system activity, assessed by Muscle Sympathetic Nerve Activity (MSNA) and Heart Rate Variability (HRV)
Time frame: After 8 weeks treatment
Markers of oxidative stress (concentrations of F2-isoprostanes in urine and oxLDL in plasma)
Time frame: After 8 weeks treatment
Markers of inflammation (hs-CRP in plasma)
Time frame: After 8 weeks treatment
Fractional sodium excretion
Time frame: After 8 weeks treatment
Arterial stiffness (assessed by pulse wave velocity and the pulse wave analysis augmentation index)
Time frame: After 8 weeks treatment
Adipose tissue function (serum concentrations of adipokines)
Time frame: After 8 weeks treatment
Lipid metabolism (serum lipid concentrations)
Time frame: After 8 weeks treatment
Insulin sensitivity, expressed by homeostatic model assessment (HOMA)
Time frame: After 8 weeks treatment
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 24 Feb 2012.
- Derived from this study: PubMed 29085669Schrover IM, Dorresteijn JAN, Smits JE, Danser AHJ, Visseren FLJ, Spiering W. Identifying treatment response to antihypertensives in patients with obesity-related hypertension. Clin Hypertens. 2017 Oct 24;23:20. doi: 10.1186/s40885-017-0077-x. eCollection 2017.
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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.
F.L.J. Visseren, Professor (MD PhD) study chair
UMC Utrecht
W. Spiering, MD PhD principal investigator
UMC Utrecht
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 Aliskiren, Moxonidine and Hydrochlorothiazide in people with Hypertension and Abdominal Obesity, run by UMC Utrecht at 1 site in Netherlands.
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 24 Feb 2012. 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 Netherlands. 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?
Endothelial function assessed by Flow Mediated Dilation (FMD) (time frame: After 8 weeks treatment). 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 NCT01138423, 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 24 Feb 2012.