Blood PressurePhase 3GenSaltNCT00721721
Analyzing Genetic Factors Involved in Blood Pressure Changes Due to Salt and Potassium Intake (The GenSalt Study)
A Phase 3 study testing Low Sodium Diet, High Sodium Diet and Potassium Supplementation in people with Blood Pressure, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in China.
Trial summary
High blood pressure is a serious health problem. In terms of diet recommendations, people with this condition are encouraged to eat a low sodium and high potassium diet. It is believed that genetics may play a role in the development of high blood pressure and may affect changes in blood pressure levels, including… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Low Sodium Diet, High Sodium Diet and Potassium Supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,906 participants
- Where
- 1 siteChina
- Study dates
- Oct 2003to May 2009
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 18 and 60 years old
- Systolic blood pressure level of 130 to 160 mm Hg and/or diastolic blood pressure level of 85 to 100 mm Hg
- Both parents (2-generation nuclear family) or at least one parent (at least a 3-generation family) is available and willing to participate in the study
- At least one sibling meets eligibility criteria for participation
- Siblings and spouses must be between 18 and 60 years old; children must be more than 16 years old
- Lives in the same village as the main study participant
Who cannot join
- Current stage 2 hypertension (systolic blood pressure level greater than or equal to 160 mm Hg and/or diastolic blood pressure level greater than or equal to 100 mm Hg)
- Current or recent (i.e., less than 1 month before the screening visit) use of antihypertensive medications or medications that affect blood pressure
- Secondary hypertension
- History of clinical cardiovascular disease, including heart attack, congestive heart failure, stroke, and peripheral arterial disease
- Chronic kidney failure or urinary albumin concentration of greater than or equal to 20 mg/dL
- Current diabetes (i.e., fasting serum glucose level greater than or equal to 126 mg/dL) or use of insulin or oral hypoglycemic agents
Show all 11Show fewer
- Peptic ulcer disease requiring treatment in the 2 years before study entry
- Liver disease requiring treatment in the 2 years before study entry
- Pregnant
- Heavy alcohol drinker (i.e., more than 14 drinks per week)
- Currently adhering to a low sodium diet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genetic Epidemiology Network of Salt Sensitivity
High blood pressure is a serious health problem. In terms of diet recommendations, people with this condition are encouraged to eat a low sodium and high potassium diet. It is believed that genetics may play a role in the development of high blood pressure and may affect changes in blood pressure levels, including changes brought on by sodium and potassium. This study will identify genetic factors that may influence blood pressure changes due to increased salt or potassium intake in people with mildly elevated blood pressure and in their family members.
Read the detailed description
High blood pressure is one of the most common health problems among adults. If left untreated, it can lead to heart failure, kidney failure, or stroke. Common causes include stress, diet, diabetes, kidney disease, or obesity. Typical treatments include taking medication, losing weight, and quitting smoking. It is also recommended that people with high blood pressure or those at risk of developing high blood pressure modify their diets to decrease sodium intake and increase potassium intake. Research has shown that genetics may play a role in the development of high blood pressure and may affect fluctuations of blood pressure levels, including blood pressure changes brought on by sodium and potassium. This study will identify and analyze the genetic factors that may be responsible for blood pressure changes due to dietary salt and potassium intake. Blood samples collected in this study may also be used for future genetic research on blood pressure.
This study will enroll people who have mildly elevated blood pressure and their siblings, spouses, and children. Participants will first take part in a 3-day observation period. At a Day 1 study visit, participants' weight, height, waist size, and blood pressure will be measured. There will be three separate blood pressure measurements. Study staff will then interview participants to collect information on family and personal medical history, cigarette smoking habits, alcohol consumption, physical activity, and diet. Finally, blood samples will be collected. For 24 hours after the first study visit, participants will collect their urine. At study visits on Days 2 and 3, participants will undergo three blood pressure measurements and a cold pressor test, which measures blood pressure at different body temperatures. Participants will also collect a urine sample each night.
After the 3-day observation period, participants will take part in a 3-week treatment period. Each day, all participants will eat breakfast, lunch, and dinner in the study kitchen. For Days 1 through 7, participants will eat a low sodium diet; for Days 7 through 14, participants will eat a high sodium diet; and for Days 14 through 21, participants will eat a high sodium diet and receive potassium supplements. Blood pressure will be measured three times per day and urine will be collected at several times during this period. Blood samples will be collected at the end of each week.
Parents of participants will also be enrolled in this study, and they will complete the same study procedures that participants complete during the 3-day observation period except for the urine collection.
The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).
- Conditions
- Blood Pressure
- Being tested
- Low Sodium Diet, High Sodium Diet, Potassium Supplementation
- Keywords
- Dietary Sodium, Dietary Potassium, Genes, Genomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Sodium DietBehavioural
3 grams of salt or 51.3 mmol of sodium per day
High Sodium DietBehavioural
18 grams of salt or 307.8 mmol of sodium per day
Potassium SupplementationDietary supplement
60 mmol potassium supplement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will follow a low sodium diet for Days 1 through 7, a high sodium diet for Days 7 through 14, and a high sodium diet plus potassium supplement regimen for Days 14 through 21. Receives: Behavioral: Low Sodium Diet; Behavioral: High Sodium Diet; Dietary Supplement: Potassium Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: Measured at Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startOct 2003
- Primary completionJul 2005
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,906 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Jiang He, MD, PhD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721721
- Sponsor's protocol ID
- 1412
- Other IDs
- U01HL072507
- Acronym
- GenSalt
- Status last verified
- Aug 2008
- First submitted
- 22 Jul 2008
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
GenSalt Collaborative Research Group. GenSalt: rationale, design, methods and baseline characteristics of study participants. J Hum Hypertens. 2007 Aug;21(8):639-46. doi: 10.1038/sj.jhh.1002207. Epub 2007 Apr 19.
PubMed 17443206Gu D, Rice T, Wang S, Yang W, Gu C, Chen CS, Hixson JE, Jaquish CE, Yao ZJ, Liu DP, Rao DC, He J. Heritability of blood pressure responses to dietary sodium and potassium intake in a Chinese population. Hypertension. 2007 Jul;50(1):116-22. doi: 10.1161/HYPERTENSIONAHA.107.088310. Epub 2007 May 7.
PubMed 17485599Xing X, Liu F, Yang X, Huang C, Zhang D, Chen S, Chen J, Li J, Liu Z, Lu F, Gu D, Huang J. Central Blood Pressure Responses to Dietary Sodium and Potassium Interventions. Am J Hypertens. 2018 Apr 13;31(5):582-589. doi: 10.1093/ajh/hpx209.
PubMed 29385399Gu X, Gu D, He J, Rao DC, Hixson JE, Chen J, Li J, Huang J, Wu X, Rice TK, Shimmin LC, Kelly TN. Resequencing Epithelial Sodium Channel Genes Identifies Rare Variants Associated With Blood Pressure Salt-Sensitivity: The GenSalt Study. Am J Hypertens. 2018 Jan 12;31(2):205-211. doi: 10.1093/ajh/hpx169.
PubMed 29036630Kelly TN, Li C, Hixson JE, Gu D, Rao DC, Huang J, Rice TK, Chen J, Cao J, Li J, Anderson CE, He J. Resequencing Study Identifies Rare Renin-Angiotensin-Aldosterone System Variants Associated With Blood Pressure Salt-Sensitivity: The GenSalt Study. Am J Hypertens. 2017 May 1;30(5):495-501. doi: 10.1093/ajh/hpx004.
PubMed 28199472Yang X, Gu D, He J, Hixson JE, Rao DC, Lu F, Mu J, Jaquish CE, Chen J, Huang J, Shimmin LC, Rice TK, Chen J, Wu X, Liu D, Kelly TN. Genome-wide linkage and regional association study of blood pressure response to the cold pressor test in Han Chinese: the genetic epidemiology network of salt sensitivity study. Circ Cardiovasc Genet. 2014 Aug;7(4):521-8. doi: 10.1161/CIRCGENETICS.113.000332. Epub 2014 Jul 15.
PubMed 25028485Zhao Q, Gu D, Chen J, Li J, Cao J, Lu F, Guo D, Wang R, Shen J, Chen J, Chen CS, Mills KT, Schwander K, Rao DC, He J. Blood pressure responses to dietary sodium and potassium interventions and the cold pressor test: the GenSalt replication study in rural North China. Am J Hypertens. 2014 Jan;27(1):72-80. doi: 10.1093/ajh/hpt163. Epub 2013 Sep 4.
PubMed 24004934Kelly TN, Rebholz CM, Gu D, Hixson JE, Rice TK, Cao J, Chen J, Li J, Lu F, Ma J, Mu J, Whelton PK, He J. Analysis of sex hormone genes reveals gender differences in the genetic etiology of blood pressure salt sensitivity: the GenSalt study. Am J Hypertens. 2013 Feb;26(2):191-200. doi: 10.1093/ajh/hps018. Epub 2012 Dec 28.
PubMed 23382403Zhao Q, Gu D, Hixson JE, Liu DP, Rao DC, Jaquish CE, Kelly TN, Lu F, Ma J, Mu J, Shimmin LC, Chen J, Mei H, Hamm LL, He J; Genetic Epidemiology Network of Salt Sensitivity Collaborative Research Group. Common variants in epithelial sodium channel genes contribute to salt sensitivity of blood pressure: The GenSalt study. Circ Cardiovasc Genet. 2011 Aug 1;4(4):375-80. doi: 10.1161/CIRCGENETICS.110.958629. Epub 2011 May 11.
PubMed 21562341Kelly TN, Hixson JE, Rao DC, Mei H, Rice TK, Jaquish CE, Shimmin LC, Schwander K, Chen CS, Liu D, Chen J, Bormans C, Shukla P, Farhana N, Stuart C, Whelton PK, He J, Gu D. Genome-wide linkage and positional candidate gene study of blood pressure response to dietary potassium intervention: the genetic epidemiology network of salt sensitivity study. Circ Cardiovasc Genet. 2010 Dec;3(6):539-47. doi: 10.1161/CIRCGENETICS.110.940635. Epub 2010 Sep 22.
PubMed 20861505Chen J, Gu D, Huang J, Rao DC, Jaquish CE, Hixson JE, Chen CS, Chen J, Lu F, Hu D, Rice T, Kelly TN, Hamm LL, Whelton PK, He J; GenSalt Collaborative Research Group. Metabolic syndrome and salt sensitivity of blood pressure in non-diabetic people in China: a dietary intervention study. Lancet. 2009 Mar 7;373(9666):829-35. doi: 10.1016/S0140-6736(09)60144-6. Epub 2009 Feb 14.
PubMed 19223069
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Epidemiology Network of Salt Sensitivity
- ClinicalTrials.gov ID
- NCT00721721
- Acronym / sponsor ID
- GenSalt / 1412
- Conditions
- Blood Pressure
- Keywords
- Dietary Sodium, Dietary Potassium, Genes, Genomics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,906 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Oct 2003
- Primary completion
- Jul 2005 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 24 Jul 2008 (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 is a serious health problem. In terms of diet recommendations, people with this condition are encouraged to eat a low sodium and high potassium diet. It is believed that genetics may play a role in the development of high blood pressure and may affect changes in blood pressure levels, including changes brought on by sodium and potassium. This study will identify genetic factors that may influence blood pressure changes due to increased salt or potassium intake in people with mildly elevated blood pressure and in their family members.
Detailed description
High blood pressure is one of the most common health problems among adults. If left untreated, it can lead to heart failure, kidney failure, or stroke. Common causes include stress, diet, diabetes, kidney disease, or obesity. Typical treatments include taking medication, losing weight, and quitting smoking. It is also recommended that people with high blood pressure or those at risk of developing high blood pressure modify their diets to decrease sodium intake and increase potassium intake. Research has shown that genetics may play a role in the development of high blood pressure and may affect fluctuations of blood pressure levels, including blood pressure changes brought on by sodium and potassium. This study will identify and analyze the genetic factors that may be responsible for blood pressure changes due to dietary salt and potassium intake. Blood samples collected in this study may also be used for future genetic research on blood pressure.
This study will enroll people who have mildly elevated blood pressure and their siblings, spouses, and children. Participants will first take part in a 3-day observation period. At a Day 1 study visit, participants' weight, height, waist size, and blood pressure will be measured. There will be three separate blood pressure measurements. Study staff will then interview participants to collect information on family and personal medical history, cigarette smoking habits, alcohol consumption, physical activity, and diet. Finally, blood samples will be collected. For 24 hours after the first study visit, participants will collect their urine. At study visits on Days 2 and 3, participants will undergo three blood pressure measurements and a cold pressor test, which measures blood pressure at different body temperatures. Participants will also collect a urine sample each night.
After the 3-day observation period, participants will take part in a 3-week treatment period. Each day, all participants will eat breakfast, lunch, and dinner in the study kitchen. For Days 1 through 7, participants will eat a low sodium diet; for Days 7 through 14, participants will eat a high sodium diet; and for Days 14 through 21, participants will eat a high sodium diet and receive potassium supplements. Blood pressure will be measured three times per day and urine will be collected at several times during this period. Blood samples will be collected at the end of each week.
Parents of participants will also be enrolled in this study, and they will complete the same study procedures that participants complete during the 3-day observation period except for the urine collection.
The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Low Sodium Diet, Behavioral: High Sodium Diet, Dietary Supplement: Potassium SupplementationParticipants will follow a low sodium diet for Days 1 through 7, a high sodium diet for Days 7 through 14, and a high sodium diet plus potassium supplement regimen for Days 14 through 21. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Between 18 and 60 years old
- Systolic blood pressure level of 130 to 160 mm Hg and/or diastolic blood pressure level of 85 to 100 mm Hg
- Both parents (2-generation nuclear family) or at least one parent (at least a 3-generation family) is available and willing to participate in the study
- At least one sibling meets eligibility criteria for participation
- Siblings and spouses must be between 18 and 60 years old; children must be more than 16 years old
Key exclusion criteria (11 listed)
- Current stage 2 hypertension (systolic blood pressure level greater than or equal to 160 mm Hg and/or diastolic blood pressure level greater than or equal to 100 mm Hg)
- Current or recent (i.e., less than 1 month before the screening visit) use of antihypertensive medications or medications that affect blood pressure
- Secondary hypertension
- History of clinical cardiovascular disease, including heart attack, congestive heart failure, stroke, and peripheral arterial disease
- Chronic kidney failure or urinary albumin concentration of greater than or equal to 20 mg/dL
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 |
|---|---|---|
| Low Sodium Diet3 grams of salt or 51.3 mmol of sodium per day | Behavioural | 1 |
| High Sodium Diet18 grams of salt or 307.8 mmol of sodium per day | Behavioural | 1 |
| Potassium Supplementation60 mmol potassium supplement | Dietary supplement | 1 |
Primary outcome
Blood pressure
Time frame: Measured at Day 21
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 29 Jul 2016.
- Results publication: PubMed 17443206GenSalt Collaborative Research Group. GenSalt: rationale, design, methods and baseline characteristics of study participants. J Hum Hypertens. 2007 Aug;21(8):639-46. doi: 10.1038/sj.jhh.1002207. Epub 2007 Apr 19.
- Results publication: PubMed 17485599Gu D, Rice T, Wang S, Yang W, Gu C, Chen CS, Hixson JE, Jaquish CE, Yao ZJ, Liu DP, Rao DC, He J. Heritability of blood pressure responses to dietary sodium and potassium intake in a Chinese population. Hypertension. 2007 Jul;50(1):116-22. doi: 10.1161/HYPERTENSIONAHA.107.088310. Epub 2007 May 7.
- Derived from this study: PubMed 29385399Xing X, Liu F, Yang X, Huang C, Zhang D, Chen S, Chen J, Li J, Liu Z, Lu F, Gu D, Huang J. Central Blood Pressure Responses to Dietary Sodium and Potassium Interventions. Am J Hypertens. 2018 Apr 13;31(5):582-589. doi: 10.1093/ajh/hpx209.
- Derived from this study: PubMed 29036630Gu X, Gu D, He J, Rao DC, Hixson JE, Chen J, Li J, Huang J, Wu X, Rice TK, Shimmin LC, Kelly TN. Resequencing Epithelial Sodium Channel Genes Identifies Rare Variants Associated With Blood Pressure Salt-Sensitivity: The GenSalt Study. Am J Hypertens. 2018 Jan 12;31(2):205-211. doi: 10.1093/ajh/hpx169.
- Derived from this study: PubMed 28199472Kelly TN, Li C, Hixson JE, Gu D, Rao DC, Huang J, Rice TK, Chen J, Cao J, Li J, Anderson CE, He J. Resequencing Study Identifies Rare Renin-Angiotensin-Aldosterone System Variants Associated With Blood Pressure Salt-Sensitivity: The GenSalt Study. Am J Hypertens. 2017 May 1;30(5):495-501. doi: 10.1093/ajh/hpx004.
- Derived from this study: PubMed 25028485Yang X, Gu D, He J, Hixson JE, Rao DC, Lu F, Mu J, Jaquish CE, Chen J, Huang J, Shimmin LC, Rice TK, Chen J, Wu X, Liu D, Kelly TN. Genome-wide linkage and regional association study of blood pressure response to the cold pressor test in Han Chinese: the genetic epidemiology network of salt sensitivity study. Circ Cardiovasc Genet. 2014 Aug;7(4):521-8. doi: 10.1161/CIRCGENETICS.113.000332. Epub 2014 Jul 15.
- Derived from this study: PubMed 24004934Zhao Q, Gu D, Chen J, Li J, Cao J, Lu F, Guo D, Wang R, Shen J, Chen J, Chen CS, Mills KT, Schwander K, Rao DC, He J. Blood pressure responses to dietary sodium and potassium interventions and the cold pressor test: the GenSalt replication study in rural North China. Am J Hypertens. 2014 Jan;27(1):72-80. doi: 10.1093/ajh/hpt163. Epub 2013 Sep 4.
- Derived from this study: PubMed 23382403Kelly TN, Rebholz CM, Gu D, Hixson JE, Rice TK, Cao J, Chen J, Li J, Lu F, Ma J, Mu J, Whelton PK, He J. Analysis of sex hormone genes reveals gender differences in the genetic etiology of blood pressure salt sensitivity: the GenSalt study. Am J Hypertens. 2013 Feb;26(2):191-200. doi: 10.1093/ajh/hps018. Epub 2012 Dec 28.
- Derived from this study: PubMed 21562341Zhao Q, Gu D, Hixson JE, Liu DP, Rao DC, Jaquish CE, Kelly TN, Lu F, Ma J, Mu J, Shimmin LC, Chen J, Mei H, Hamm LL, He J; Genetic Epidemiology Network of Salt Sensitivity Collaborative Research Group. Common variants in epithelial sodium channel genes contribute to salt sensitivity of blood pressure: The GenSalt study. Circ Cardiovasc Genet. 2011 Aug 1;4(4):375-80. doi: 10.1161/CIRCGENETICS.110.958629. Epub 2011 May 11.
- Derived from this study: PubMed 20861505Kelly TN, Hixson JE, Rao DC, Mei H, Rice TK, Jaquish CE, Shimmin LC, Schwander K, Chen CS, Liu D, Chen J, Bormans C, Shukla P, Farhana N, Stuart C, Whelton PK, He J, Gu D. Genome-wide linkage and positional candidate gene study of blood pressure response to dietary potassium intervention: the genetic epidemiology network of salt sensitivity study. Circ Cardiovasc Genet. 2010 Dec;3(6):539-47. doi: 10.1161/CIRCGENETICS.110.940635. Epub 2010 Sep 22.
- Derived from this study: PubMed 19223069Chen J, Gu D, Huang J, Rao DC, Jaquish CE, Hixson JE, Chen CS, Chen J, Lu F, Hu D, Rice T, Kelly TN, Hamm LL, Whelton PK, He J; GenSalt Collaborative Research Group. Metabolic syndrome and salt sensitivity of blood pressure in non-diabetic people in China: a dietary intervention study. Lancet. 2009 Mar 7;373(9666):829-35. doi: 10.1016/S0140-6736(09)60144-6. Epub 2009 Feb 14.
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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.
Jiang He, MD, PhD principal investigator
Tulane University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low Sodium Diet, High Sodium Diet and Potassium Supplementation in people with Blood Pressure, run by National Heart, Lung, and Blood Institute (NHLBI) 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 6 inclusion and 11 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 29 Jul 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Measured at Day 21). 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 NCT00721721, which also lists 11 linked publications.
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 29 Jul 2016.