HypertensionPhase 2/3SILVHIANCT00389168

Irbesartan and Atenolol in Hypertensive Heart Disease

A Phase 2/3 study testing Irbesartan and Atenolol in people with Hypertension, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The renin-angiotensin-aldosterone system has been implicated in the control of structural changes of the heart and the vasculature, beyond the effects on blood pressure. This projects examines the importance of the renin-angiotensin-aldosterone system and the sympathetic nervous system in the control of cardiac and… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Hypertension
What is being tested?: Irbesartan and Atenolol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 115 participants
Where: 1 siteSweden
Study dates: Apr 1995to Apr 1997
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

At least 18 ys old
Male or female with no child bearing potential
Seated blood pressure diastolic 90-115 mm Hg
Left ventricular mass above 131 g/m2 for men, above 100 g/m2 for women
Informed consent

Who cannot join

Coronary artery disease, heart failure or other significant cardiac disorder
Cerebrovascular accident within the past 6 months
A seated systolic blood pressure above 200 mm Hg
Significant renal disease, collagen or vascular disease, or gastrointestinal condition
Significant allergy or intolerance to study drug
Alcohol or drug abuse
Uncontrolled diabetes mellitus

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Karolinska Institutet, Daprtment of Clinical Sciences, Danderyd Hospital, Cardiovascular Research Laboratory
Stockholm, SE-182 88

Other trials in Sweden

About this study

Official title: Randomized, Double-blind Evaluation of the Effects of Irbesartan and Atenolol on Cardiovascular Structure and Function in Subjects With Hypertension and Left Ventricular Hypertrophy

The renin-angiotensin-aldosterone system has been implicated in the control of structural changes of the heart and the vasculature, beyond the effects on blood pressure.

This projects examines the importance of the renin-angiotensin-aldosterone system and the sympathetic nervous system in the control of cardiac and vascular structure and function in subjects with hypertension.Patients with hypertension and left ventricular hypertrophy were randomized to an angiotensin receptor blocker or a beta adrenergic receptor blocker for 48 weeks. Repeat investigations of blood pressure, structure and function of the heart and the vascular tree, and neurohormones were performed. Two control groups, consisting of normotensive subjects and of hypertensive subjects with no cardiac hypertrophy were also examined for comparison.

Read the detailed description

We included 115 patients with hypertension and cardiac hypertrophy, established by echocardiography. Extensive echocardiographic examinations, ultrasonography of the carotid arteries, 24h Holter registrations, 24h ambulatory blood pressure monitoring monitoring, neurohormones and blood samples for inflammation and hemostasis markers and endothelial function were done at weeks 0, 12, 24, and 48. Matched control groups (1:3, i.e. 38 normotensive subjects and 38 hypertensive subjects with no signs of hypertensive heart disease were examined at one occasion. All patients obtained irbesartan or atenolol for 12 weeks; a diuretic and a calcium antagonist was added when needed thereafter in order to obtained a blood pressure below 140/90 mm Hg. All analyses were performed central in a core laboratory.

Conditions: Hypertension
Being tested: Irbesartan, Atenolol
Keywords: Hypertension, Cardiac hypertrophy, Angiotensin, Human
Medical subject headings: Hypertension, Cardiomegaly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IrbesartanDrug
Also called Aprovel
Titrated to 300 mg od, 48 weeks.
AtenololDrug
Also called Tenormin
Titrated to 100 mg od, 48 weeks.

Study groups in NCT00389168
Study group	Role	What they receive
Irbesartan	Experimental	Irbesartan per os titrated to 300 mg od, 48 weeks Receives: Drug: Irbesartan
Atenolol	Active comparator	Atenolol per os titrated to 100 mg od, 48 weeks Receives: Drug: Atenolol

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Left Ventricular Mass Index
Repeated measures multivariate analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks. Data are presented as left ventricular mass in gram (g) indexed for body mass index (in m^2).
Measured: Baseline and 48 weeks

Secondary outcomes (5)

Number of Participants With Serious Adverse Events
Safety was assessed by non-directed questions, and all observed and volunteered adverse events were recorded at each study visit. Serious adverse events were defined by, and reported according to the regulations of good clinical practice (GCP). none were considered related to the study medication.
Measured: Treatment period was baseline to 48 weeks
Left Ventricular Diastolic Function Assessed by the E/A Ratio
Changes in left ventricular diastolic function from baseline to week 48 will be evaluated as the difference in E/A ratio. Conventional pulsed wave Doppler echocardiography was used for recordings of mitral inflow in. The peak of early (E) and late (A) mitral flow velocities were measured, and the E/A-ratio was calculated. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Some echocardiographic recordings at some time point may be of insufficient quality or missing, and the number of observations may not always correspond to the total number of participants at all time points.
Measured: Baseline to 48 weeks
Blood Pressure
Difference in Diastolic Blood Pressure. Repeated measures multivariable analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks
Measured: Baseline to 48 weeks
Changes of Venous Plasma Angiotensin II as a Marker of the Renin-Angiotensin-Aldosterone System
Venous plasma concentrations of angiotensin II were measured in order to study the possible associations between the activity of the renin-angiotensin-aldosteone system and changes in left ventricular mass. Further analyses of other components of the renin-angiotensin-aldosterone system and of other hormonal system (e.g. the sympathetic nervous system) have also been performed and published. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Data were log-transformed to avoid skewness before statistical evaluation. However, tabular data are given as mean values with 95% confidence to improve readability.
Measured: Baseline to 48 weeks
Effects on Carotid Artery Wall Thickness
Changes in common carotid artery intima-media thickness, assessed by ultrasonography.
Measured: Baseline to 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 1995Apr 1997

First posted18 Oct 2006 (estimated)
Study startApr 1995
Primary completionApr 1997
Study completionApr 1997

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (14)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Karolinska InstitutetThe 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00389168
Sponsor's protocol ID: CV131-052
Acronym: SILVHIA
Status last verified: May 2015
First submitted: 17 Oct 2006
Last updated: 5 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Malmqvist K, Kahan T, Edner M, Held C, Hagg A, Lind L, Muller-Brunotte R, Nystrom F, Ohman KP, Osbakken MD, Ostergern J. Regression of left ventricular hypertrophy in human hypertension with irbesartan. J Hypertens. 2001 Jun;19(6):1167-76. doi: 10.1097/00004872-200106000-00023.
PubMed 11403367
Nystrom F, Malmqvist K, Ohman KP, Kahan T. Nurse-recorded and ambulatory blood pressure predicts treatment-induced reduction of left ventricular hypertrophy equally well in hypertension: results from the Swedish irbesartan left ventricular hypertrophy investigation versus atenolol (SILVHIA) study. J Hypertens. 2002 Aug;20(8):1527-33. doi: 10.1097/00004872-200208000-00015.
PubMed 12172314
Malmqvist K, Kahan T, Edner M, Bergfeldt L. Comparison of actions of irbesartan versus atenolol on cardiac repolarization in hypertensive left ventricular hypertrophy: results from the Swedish Irbesartan Left Ventricular Hypertrophy Investigation Versus Atenolol (SILVHIA). Am J Cardiol. 2002 Nov 15;90(10):1107-12. doi: 10.1016/s0002-9149(02)02777-7.
PubMed 12423712
Malmqvist K, Ohman KP, Lind L, Nystrom F, Kahan T. Long-term effects of irbesartan and atenolol on the renin-angiotensin-aldosterone system in human primary hypertension: the Swedish Irbesartan Left Ventricular Hypertrophy Investigation versus Atenolol (SILVHIA). J Cardiovasc Pharmacol. 2003 Dec;42(6):719-26. doi: 10.1097/00005344-200312000-00005.
PubMed 14639093
Muller-Brunotte R, Kahan T, Malmqvist K, Ring M, Edner M. Tissue velocity echocardiography shows early improvement in diastolic function with irbesartan and atenolol therapy in patients with hypertensive left ventricular hypertrophy. Results form the Swedish Irbesartan Left Ventricular Hypertrophy Investigation vs Atenolol (SILVHIA). Am J Hypertens. 2006 Sep;19(9):927-36. doi: 10.1016/j.amjhyper.2006.02.009.
PubMed 16942935
Mortsell D, Malmqvist K, Held C, Kahan T. Irbesartan reduces common carotid artery intima-media thickness in hypertensive patients when compared with atenolol: the Swedish Irbesartan Left Ventricular Hypertrophy Investigation versus Atenolol (SILVHIA) study. J Intern Med. 2007 May;261(5):472-9. doi: 10.1111/j.1365-2796.2007.01775.x.
PubMed 17444886
Malmqvist K, Kahan T, Edner M, Bergfeldt L. Cardiac repolarization and its relation to ventricular geometry and rate in reverse remodelling during antihypertensive therapy with irbesartan or atenolol: results from the SILVHIA study. J Hum Hypertens. 2007 Dec;21(12):956-65. doi: 10.1038/sj.jhh.1002250. Epub 2007 Jul 19.
PubMed 17637792
Muller-Brunotte R, Kahan T, Lopez B, Edner M, Gonzalez A, Diez J, Malmqvist K. Myocardial fibrosis and diastolic dysfunction in patients with hypertension: results from the Swedish Irbesartan Left Ventricular Hypertrophy Investigation versus Atenolol (SILVHIA). J Hypertens. 2007 Sep;25(9):1958-66. doi: 10.1097/HJH.0b013e3282170ada.
PubMed 17762662
Kurland L, Hallberg P, Melhus H, Liljedahl U, Hashemi N, Syvanen AC, Lind L, Kahan T. The relationship between the plasma concentration of irbesartan and the antihypertensive response is disclosed by an angiotensin II type 1 receptor polymorphism: results from the Swedish Irbesartan Left Ventricular Hypertrophy Investigation vs. Atenolol (SILVHIA) Trial. Am J Hypertens. 2008 Jul;21(7):836-9. doi: 10.1038/ajh.2008.190. Epub 2008 May 8.
PubMed 18464745
Liljedahl S, Kahan T, Lind L, Arnlov J. The effects of antihypertensive treatment on the doppler-derived myocardial performance index in patients with hypertensive left ventricular hypertrophy: results from the Swedish irbesartan in left ventricular hypertrophy investigation versus atenolol (SILVHIA). Echocardiography. 2009 Aug;26(7):753-8. doi: 10.1111/j.1540-8175.2008.00886.x.
PubMed 19486119
Muller-Brunotte R, Kahan T, Malmqvist K, Edner M; Swedish ibesartan left ventricular hypertrophy investigation vs atenolol (SILVHIA). Blood pressure and left ventricular geometric pattern determine diastolic function in hypertensive myocardial hypertrophy. J Hum Hypertens. 2003 Dec;17(12):841-9. doi: 10.1038/sj.jhh.1001622.
PubMed 14704728
Muller-Brunotte R, Edner M, Malmqvist K, Kahan T. Irbesartan and atenolol improve diastolic function in patients with hypertensive left ventricular hypertrophy. J Hypertens. 2005 Mar;23(3):633-40. doi: 10.1097/01.hjh.0000160222.17092.b8.
PubMed 15716707
Jekell A, Malmqvist K, Wallen NH, Mortsell D, Kahan T. Markers of inflammation, endothelial activation, and arterial stiffness in hypertensive heart disease and the effects of treatment: results from the SILVHIA study. J Cardiovasc Pharmacol. 2013 Dec;62(6):559-66. doi: 10.1097/FJC.0000000000000017.
PubMed 24084214
Kurland L, Liljedahl U, Karlsson J, Kahan T, Malmqvist K, Melhus H, Syvanen AC, Lind L. Angiotensinogen gene polymorphisms: relationship to blood pressure response to antihypertensive treatment. Results from the Swedish Irbesartan Left Ventricular Hypertrophy Investigation vs Atenolol (SILVHIA) trial. Am J Hypertens. 2004 Jan;17(1):8-13. doi: 10.1016/j.amjhyper.2003.09.009.
PubMed 14700505

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-blind Evaluation of the Effects of Irbesartan and Atenolol on Cardiovascular Structure and Function in Subjects With Hypertension and Left Ventricular Hypertrophy
ClinicalTrials.gov ID: NCT00389168
Acronym / sponsor ID: SILVHIA / CV131-052
Conditions: Hypertension
Keywords: Hypertension, Cardiac hypertrophy, Angiotensin, Human
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 115 participants (actual)
Lead sponsor: Karolinska InstitutetUniversity, hospital or other
Collaborators: Bristol-Myers Squibb, Sanofi, Swedish Heart Lung Foundation
Study start: Apr 1995
Primary completion: Apr 1997 (actual)
Study completion: Apr 1997 (actual)
First posted: 18 Oct 2006 (estimated)
Results: Posted 5 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The renin-angiotensin-aldosterone system has been implicated in the control of structural changes of the heart and the vasculature, beyond the effects on blood pressure.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Irbesartan	Experimental	Drug: IrbesartanIrbesartan per os titrated to 300 mg od, 48 weeks
Atenolol	Active comparator	Drug: AtenololAtenolol per os titrated to 100 mg od, 48 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

At least 18 ys old
Male or female with no child bearing potential
Seated blood pressure diastolic 90-115 mm Hg
Left ventricular mass above 131 g/m2 for men, above 100 g/m2 for women
Informed consent

Key exclusion criteria (7 listed)

Coronary artery disease, heart failure or other significant cardiac disorder
Cerebrovascular accident within the past 6 months
A seated systolic blood pressure above 200 mm Hg
Significant renal disease, collagen or vascular disease, or gastrointestinal condition
Significant allergy or intolerance to study drug

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
IrbesartanAlso: AprovelTitrated to 300 mg od, 48 weeks.	Drug	Irbesartan
AtenololAlso: TenorminTitrated to 100 mg od, 48 weeks.	Drug	Atenolol

Primary outcome

Changes in Left Ventricular Mass Index
Time frame: Baseline and 48 weeks
Repeated measures multivariate analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks. Data are presented as left ventricular mass in gram (g) indexed for body mass index (in m^2).

5 secondary outcomes

Number of Participants With Serious Adverse Events
Time frame: Treatment period was baseline to 48 weeks
Left Ventricular Diastolic Function Assessed by the E/A Ratio
Time frame: Baseline to 48 weeks
Blood Pressure
Time frame: Baseline to 48 weeks
Changes of Venous Plasma Angiotensin II as a Marker of the Renin-Angiotensin-Aldosterone System
Time frame: Baseline to 48 weeks
Effects on Carotid Artery Wall Thickness
Time frame: Baseline to 48 weeks

Results and safety

Results posted to the registry on 5 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Irbesartan	56	47
Atenolol	58	53

Primary outcome: Changes in Left Ventricular Mass Index

Time frame: Baseline and 48 weeks. Mean (95% Confidence Interval). Unit: g/m^2

Measure	Atenolol n = 50	Irbesartan n = 44
12 weeks	-1 (-6 to 4)	-9 (-15 to -6)
24 weeks	-6 (-12 to 0)	-14 (-22 to -6)
48 weeks	-14 (-20 to 9)	-26 (-34 to -18)

Population analysed: Data on echocardiography is not always available at all time points and for all participants. This is reflected by the number of observations, which sometimes are less than the number of participants.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: The entire duration of study: that is 4-6 weeks of single-blinded placebo run-in, 48 weeks of double-blinded medication, and 4 weeks following completion of the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Irbesratan	5 of 56 (8.9%)	0 of 56 (0%)	Not reported
Atenolol	5 of 58 (8.6%)	0 of 58 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 11403367Malmqvist K, Kahan T, Edner M, Held C, Hagg A, Lind L, Muller-Brunotte R, Nystrom F, Ohman KP, Osbakken MD, Ostergern J. Regression of left ventricular hypertrophy in human hypertension with irbesartan. J Hypertens. 2001 Jun;19(6):1167-76. doi: 10.1097/00004872-200106000-00023.
Results publication: PubMed 12172314Nystrom F, Malmqvist K, Ohman KP, Kahan T. Nurse-recorded and ambulatory blood pressure predicts treatment-induced reduction of left ventricular hypertrophy equally well in hypertension: results from the Swedish irbesartan left ventricular hypertrophy investigation versus atenolol (SILVHIA) study. J Hypertens. 2002 Aug;20(8):1527-33. doi: 10.1097/00004872-200208000-00015.
Results publication: PubMed 12423712Malmqvist K, Kahan T, Edner M, Bergfeldt L. Comparison of actions of irbesartan versus atenolol on cardiac repolarization in hypertensive left ventricular hypertrophy: results from the Swedish Irbesartan Left Ventricular Hypertrophy Investigation Versus Atenolol (SILVHIA). Am J Cardiol. 2002 Nov 15;90(10):1107-12. doi: 10.1016/s0002-9149(02)02777-7.
Results publication: PubMed 14639093Malmqvist K, Ohman KP, Lind L, Nystrom F, Kahan T. Long-term effects of irbesartan and atenolol on the renin-angiotensin-aldosterone system in human primary hypertension: the Swedish Irbesartan Left Ventricular Hypertrophy Investigation versus Atenolol (SILVHIA). J Cardiovasc Pharmacol. 2003 Dec;42(6):719-26. doi: 10.1097/00005344-200312000-00005.
Results publication: PubMed 16942935Muller-Brunotte R, Kahan T, Malmqvist K, Ring M, Edner M. Tissue velocity echocardiography shows early improvement in diastolic function with irbesartan and atenolol therapy in patients with hypertensive left ventricular hypertrophy. Results form the Swedish Irbesartan Left Ventricular Hypertrophy Investigation vs Atenolol (SILVHIA). Am J Hypertens. 2006 Sep;19(9):927-36. doi: 10.1016/j.amjhyper.2006.02.009.
Results publication: PubMed 17444886Mortsell D, Malmqvist K, Held C, Kahan T. Irbesartan reduces common carotid artery intima-media thickness in hypertensive patients when compared with atenolol: the Swedish Irbesartan Left Ventricular Hypertrophy Investigation versus Atenolol (SILVHIA) study. J Intern Med. 2007 May;261(5):472-9. doi: 10.1111/j.1365-2796.2007.01775.x.
Results publication: PubMed 17637792Malmqvist K, Kahan T, Edner M, Bergfeldt L. Cardiac repolarization and its relation to ventricular geometry and rate in reverse remodelling during antihypertensive therapy with irbesartan or atenolol: results from the SILVHIA study. J Hum Hypertens. 2007 Dec;21(12):956-65. doi: 10.1038/sj.jhh.1002250. Epub 2007 Jul 19.
Results publication: PubMed 17762662Muller-Brunotte R, Kahan T, Lopez B, Edner M, Gonzalez A, Diez J, Malmqvist K. Myocardial fibrosis and diastolic dysfunction in patients with hypertension: results from the Swedish Irbesartan Left Ventricular Hypertrophy Investigation versus Atenolol (SILVHIA). J Hypertens. 2007 Sep;25(9):1958-66. doi: 10.1097/HJH.0b013e3282170ada.
Results publication: PubMed 18464745Kurland L, Hallberg P, Melhus H, Liljedahl U, Hashemi N, Syvanen AC, Lind L, Kahan T. The relationship between the plasma concentration of irbesartan and the antihypertensive response is disclosed by an angiotensin II type 1 receptor polymorphism: results from the Swedish Irbesartan Left Ventricular Hypertrophy Investigation vs. Atenolol (SILVHIA) Trial. Am J Hypertens. 2008 Jul;21(7):836-9. doi: 10.1038/ajh.2008.190. Epub 2008 May 8.
Results publication: PubMed 19486119Liljedahl S, Kahan T, Lind L, Arnlov J. The effects of antihypertensive treatment on the doppler-derived myocardial performance index in patients with hypertensive left ventricular hypertrophy: results from the Swedish irbesartan in left ventricular hypertrophy investigation versus atenolol (SILVHIA). Echocardiography. 2009 Aug;26(7):753-8. doi: 10.1111/j.1540-8175.2008.00886.x.
Results publication: PubMed 14704728Muller-Brunotte R, Kahan T, Malmqvist K, Edner M; Swedish ibesartan left ventricular hypertrophy investigation vs atenolol (SILVHIA). Blood pressure and left ventricular geometric pattern determine diastolic function in hypertensive myocardial hypertrophy. J Hum Hypertens. 2003 Dec;17(12):841-9. doi: 10.1038/sj.jhh.1001622.
Results publication: PubMed 15716707Muller-Brunotte R, Edner M, Malmqvist K, Kahan T. Irbesartan and atenolol improve diastolic function in patients with hypertensive left ventricular hypertrophy. J Hypertens. 2005 Mar;23(3):633-40. doi: 10.1097/01.hjh.0000160222.17092.b8.

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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.

Thomas Kahan, MD, PhD study chair

Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, SE-182 88 Stockholm, Sweden

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Irbesartan and Atenolol in people with Hypertension, run by Karolinska Institutet at 1 site in Sweden.

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 7 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 5 May 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 Sweden. 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 combined 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.

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?

Yes. Results are posted in the registry (first posted 5 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Changes in Left Ventricular Mass Index (time frame: Baseline and 48 weeks). 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 NCT00389168, which also lists 14 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 5 May 2015.