HypertensionPhase 2NCT00089713
Systolic Pressure Efficacy and Safety Trial of Alagebrium (SPECTRA)
A Phase 2 study testing alagebrium chloride (ALT-711) in people with Hypertension, run by Synvista Therapeutics, Inc at 1 site in United States.
Trial summary
This study comprises a 3- to 6-week hydrochlorothiazide run in phase, followed by a 12 week double-blind treatment phase, followed by a 2 week single-blind follow-up hydrochlorothiazide treatment phase. The combined total duration of patient participation is approximately 17-20 weeks. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- alagebrium chloride (ALT-711)
- How many people
- 392 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to not given
- Phase
- Phase 2
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women at least 45 years of age with uncontrolled systolic hypertension measured by office cuff and by an ambulatory blood pressure monitoring device
- Willingness to be taken off any current antihypertensive treatment to be placed on hydrochlorothiazide in combination with study medication.
Who cannot join
- Any significant history, systemic illnesses, or medical condition(s) that could lead to difficulty complying with the protocol or that could confound interpretation of the data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of ALT-711 in Combination With Fixed-Dose Hydrochlorothiazide Therapy on Systolic Blood Pressure in Hypertensive Patients
This study comprises a 3- to 6-week hydrochlorothiazide run in phase, followed by a 12 week double-blind treatment phase, followed by a 2 week single-blind follow-up hydrochlorothiazide treatment phase. The combined total duration of patient participation is approximately 17-20 weeks. Four double-blind treatment groups approximately equal in size (98) will comprise the study population: placebo or various alagebrium dose groups (10, 50, or 150 mg/day).
- Conditions
- Hypertension
- Being tested
- alagebrium chloride (ALT-711)
- Keywords
- antihypertensive agents/therapeutic use, hypertension/drug therapy, blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alagebrium chloride (ALT-711)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2004 (estimated)
- Study startMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 392 participants
Sponsor and investigators
- Lead sponsor
- Synvista Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Milan Kovacevic, MD, PhD, Study director, Synvista Therapeutics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089713
- Sponsor's protocol ID
- ALT-711-0320
- Status last verified
- Jun 2005
- First submitted
- 10 Aug 2004
- Last updated
- 8 Feb 2010
- Results posted
- No
Publications
Kass DA, Shapiro EP, Kawaguchi M, Capriotti AR, Scuteri A, deGroof RC, Lakatta EG. Improved arterial compliance by a novel advanced glycation end-product crosslink breaker. Circulation. 2001 Sep 25;104(13):1464-70. doi: 10.1161/hc3801.097806.
PubMed 11571237Asif M, Egan J, Vasan S, Jyothirmayi GN, Masurekar MR, Lopez S, Williams C, Torres RL, Wagle D, Ulrich P, Cerami A, Brines M, Regan TJ. An advanced glycation endproduct cross-link breaker can reverse age-related increases in myocardial stiffness. Proc Natl Acad Sci U S A. 2000 Mar 14;97(6):2809-13. doi: 10.1073/pnas.040558497.
PubMed 10706607Wolffenbuttel BH, Boulanger CM, Crijns FR, Huijberts MS, Poitevin P, Swennen GN, Vasan S, Egan JJ, Ulrich P, Cerami A, Levy BI. Breakers of advanced glycation end products restore large artery properties in experimental diabetes. Proc Natl Acad Sci U S A. 1998 Apr 14;95(8):4630-4. doi: 10.1073/pnas.95.8.4630.
PubMed 9539789Vaitkevicius PV, Lane M, Spurgeon H, Ingram DK, Roth GS, Egan JJ, Vasan S, Wagle DR, Ulrich P, Brines M, Wuerth JP, Cerami A, Lakatta EG. A cross-link breaker has sustained effects on arterial and ventricular properties in older rhesus monkeys. Proc Natl Acad Sci U S A. 2001 Jan 30;98(3):1171-5. doi: 10.1073/pnas.98.3.1171.
PubMed 11158613Chobanian AV. Control of hypertension--an important national priority. N Engl J Med. 2001 Aug 16;345(7):534-5. doi: 10.1056/NEJM200108163450709. No abstract available.
PubMed 11519509Hyman DJ, Pavlik VN. Characteristics of patients with uncontrolled hypertension in the United States. N Engl J Med. 2001 Aug 16;345(7):479-86. doi: 10.1056/NEJMoa010273.
PubMed 11519501Wilkinson IB, Webb Christison DJ, Cockcroft JR. Isolated systolic hypertension: a radical rethink. It's a risk factor that needs treatment, especially in the over 50s. BMJ. 2000 Jun 24;320(7251):1685. doi: 10.1136/bmj.320.7251.1685. No abstract available.
PubMed 10864525Brownlee M, Vlassara H, Kooney A, Ulrich P, Cerami A. Aminoguanidine prevents diabetes-induced arterial wall protein cross-linking. Science. 1986 Jun 27;232(4758):1629-32. doi: 10.1126/science.3487117.
PubMed 3487117Neaton JD, Wentworth D. Serum cholesterol, blood pressure, cigarette smoking, and death from coronary heart disease. Overall findings and differences by age for 316,099 white men. Multiple Risk Factor Intervention Trial Research Group. Arch Intern Med. 1992 Jan;152(1):56-64.
PubMed 1728930Liu J, Masurekar MR, Vatner DE, Jyothirmayi GN, Regan TJ, Vatner SF, Meggs LG, Malhotra A. Glycation end-product cross-link breaker reduces collagen and improves cardiac function in aging diabetic heart. Am J Physiol Heart Circ Physiol. 2003 Dec;285(6):H2587-91. doi: 10.1152/ajpheart.00516.2003. Epub 2003 Aug 28.
PubMed 12946933
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of ALT-711 in Combination With Fixed-Dose Hydrochlorothiazide Therapy on Systolic Blood Pressure in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT00089713
- Acronym / sponsor ID
- ALT-711-0320
- Conditions
- Hypertension
- Keywords
- antihypertensive agents/therapeutic use, hypertension/drug therapy, blood pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 392 participants
- Lead sponsor
- Synvista Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- First posted
- 12 Aug 2004 (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.
This study comprises a 3- to 6-week hydrochlorothiazide run in phase, followed by a 12 week double-blind treatment phase, followed by a 2 week single-blind follow-up hydrochlorothiazide treatment phase. The combined total duration of patient participation is approximately 17-20 weeks. Four double-blind treatment groups approximately equal in size (98) will comprise the study population: placebo or various alagebrium dose groups (10, 50, or 150 mg/day).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men or women at least 45 years of age with uncontrolled systolic hypertension measured by office cuff and by an ambulatory blood pressure monitoring device
- Willingness to be taken off any current antihypertensive treatment to be placed on hydrochlorothiazide in combination with study medication.
Key exclusion criteria (1 listed)
- Any significant history, systemic illnesses, or medical condition(s) that could lead to difficulty complying with the protocol or that could confound interpretation of the data.
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 |
|---|---|---|
| alagebrium chloride (ALT-711) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2010.
- Background: PubMed 11571237Kass DA, Shapiro EP, Kawaguchi M, Capriotti AR, Scuteri A, deGroof RC, Lakatta EG. Improved arterial compliance by a novel advanced glycation end-product crosslink breaker. Circulation. 2001 Sep 25;104(13):1464-70. doi: 10.1161/hc3801.097806.
- Background: PubMed 10706607Asif M, Egan J, Vasan S, Jyothirmayi GN, Masurekar MR, Lopez S, Williams C, Torres RL, Wagle D, Ulrich P, Cerami A, Brines M, Regan TJ. An advanced glycation endproduct cross-link breaker can reverse age-related increases in myocardial stiffness. Proc Natl Acad Sci U S A. 2000 Mar 14;97(6):2809-13. doi: 10.1073/pnas.040558497.
- Background: PubMed 9539789Wolffenbuttel BH, Boulanger CM, Crijns FR, Huijberts MS, Poitevin P, Swennen GN, Vasan S, Egan JJ, Ulrich P, Cerami A, Levy BI. Breakers of advanced glycation end products restore large artery properties in experimental diabetes. Proc Natl Acad Sci U S A. 1998 Apr 14;95(8):4630-4. doi: 10.1073/pnas.95.8.4630.
- Background: PubMed 11158613Vaitkevicius PV, Lane M, Spurgeon H, Ingram DK, Roth GS, Egan JJ, Vasan S, Wagle DR, Ulrich P, Brines M, Wuerth JP, Cerami A, Lakatta EG. A cross-link breaker has sustained effects on arterial and ventricular properties in older rhesus monkeys. Proc Natl Acad Sci U S A. 2001 Jan 30;98(3):1171-5. doi: 10.1073/pnas.98.3.1171.
- Background: PubMed 11519509Chobanian AV. Control of hypertension--an important national priority. N Engl J Med. 2001 Aug 16;345(7):534-5. doi: 10.1056/NEJM200108163450709. No abstract available.
- Background: PubMed 11519501Hyman DJ, Pavlik VN. Characteristics of patients with uncontrolled hypertension in the United States. N Engl J Med. 2001 Aug 16;345(7):479-86. doi: 10.1056/NEJMoa010273.
- Background: PubMed 10864525Wilkinson IB, Webb Christison DJ, Cockcroft JR. Isolated systolic hypertension: a radical rethink. It's a risk factor that needs treatment, especially in the over 50s. BMJ. 2000 Jun 24;320(7251):1685. doi: 10.1136/bmj.320.7251.1685. No abstract available.
- Background: PubMed 3487117Brownlee M, Vlassara H, Kooney A, Ulrich P, Cerami A. Aminoguanidine prevents diabetes-induced arterial wall protein cross-linking. Science. 1986 Jun 27;232(4758):1629-32. doi: 10.1126/science.3487117.
- Background: PubMed 1728930Neaton JD, Wentworth D. Serum cholesterol, blood pressure, cigarette smoking, and death from coronary heart disease. Overall findings and differences by age for 316,099 white men. Multiple Risk Factor Intervention Trial Research Group. Arch Intern Med. 1992 Jan;152(1):56-64.
- Background: PubMed 12946933Liu J, Masurekar MR, Vatner DE, Jyothirmayi GN, Regan TJ, Vatner SF, Meggs LG, Malhotra A. Glycation end-product cross-link breaker reduces collagen and improves cardiac function in aging diabetic heart. Am J Physiol Heart Circ Physiol. 2003 Dec;285(6):H2587-91. doi: 10.1152/ajpheart.00516.2003. Epub 2003 Aug 28.
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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.
Milan Kovacevic, MD, PhD study director
Synvista Therapeutics, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing alagebrium chloride (ALT-711) in people with Hypertension, run by Synvista Therapeutics, Inc at 1 site in United States.
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 2 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: stopped early, as of the sponsor's last update on 8 Feb 2010. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00089713, which also lists 10 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 8 Feb 2010.