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Trial record 24 of 116 for:    Atenolol

Irbesartan and Atenolol in Hypertensive Heart Disease (SILVHIA)

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ClinicalTrials.gov Identifier: NCT00389168
Recruitment Status : Completed
First Posted : October 18, 2006
Results First Posted : May 5, 2015
Last Update Posted : May 5, 2015
Sponsor:
Collaborators:
Bristol-Myers Squibb
Sanofi
Swedish Heart Lung Foundation
Information provided by (Responsible Party):
Thomas Kahan, Karolinska Institutet

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Irbesartan
Drug: Atenolol
Enrollment 115
Recruitment Details Multicenter Swedish study. Patients with primary hypertension and left ventricular (LV) hypertrophy.
Pre-assignment Details

All participants received a placebo washout period during 4 weeks at the beginning of the study.

One patient of the 115 included was during the course of the study diagnosed with Mb Conn (adrenal tumor causing endocrine secondary hypertension). This patient was excluded from all analyses. Thus, there are 114 patients included in the dataset.

Arm/Group Title Irbesartan Atenolol
Hide Arm/Group Description A double blind study with parallel group treatment with irbesartan or atenolol; addition of hydrochlorothiazide (HCTZ) and felodipine when needed to achieve < 140/90 mm Hg A double blind study with parallel group treatment with irbesartan or atenolol; addition of hydrochlorothiazide (HCTZ) and felodipine when needed to achieve < 140/90 mm Hg
Period Title: Overall Study
Started 56 58
Completed 47 53
Not Completed 9 5
Arm/Group Title Atenolol Irbesartan Total
Hide Arm/Group Description A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg Total of all reporting groups
Overall Number of Baseline Participants 58 56 114
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 56 participants 114 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
51
  87.9%
49
  87.5%
100
  87.7%
>=65 years
7
  12.1%
7
  12.5%
14
  12.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 56 participants 114 participants
54  (10) 54  (8) 54  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 56 participants 114 participants
Female
18
  31.0%
20
  35.7%
38
  33.3%
Male
40
  69.0%
36
  64.3%
76
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 58 participants 56 participants 114 participants
58 56 114
1.Primary Outcome
Title Changes in Left Ventricular Mass Index
Hide Description 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).
Time Frame Baseline and 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Atenolol Irbesartan
Hide Arm/Group Description:
A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
Overall Number of Participants Analyzed 50 44
Mean (95% Confidence Interval)
Unit of Measure: g/m^2
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)
2.Secondary Outcome
Title Number of Participants With Serious Adverse Events
Hide Description 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.
Time Frame Treatment period was baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atenolol Irbesartan
Hide Arm/Group Description:
A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
Overall Number of Participants Analyzed 58 56
Measure Type: Number
Unit of Measure: Participants
5 5
3.Secondary Outcome
Title Left Ventricular Diastolic Function Assessed by the E/A Ratio
Hide Description 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.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atenolol Irbesartan
Hide Arm/Group Description:
A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
Overall Number of Participants Analyzed 50 45
Mean (Standard Deviation)
Unit of Measure: ratio
Week 12 0.18  (0.23) 0.10  (0.22)
Week 24 0.16  (0.28) 0.04  (0.18)
Week 48 0.13  (0.24) 0.10  (0.21)
4.Secondary Outcome
Title Blood Pressure
Hide Description Difference in Diastolic Blood Pressure. Repeated measures multivariable analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atenolol Irbesartan
Hide Arm/Group Description:
A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
Overall Number of Participants Analyzed 53 47
Mean (95% Confidence Interval)
Unit of Measure: mm Hg
-16.3
(-18.5 to -14.0)
-18.8
(-21.4 to -16.3)
5.Secondary Outcome
Title Changes of Venous Plasma Angiotensin II as a Marker of the Renin-Angiotensin-Aldosterone System
Hide Description 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.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atenolol Irbesartan
Hide Arm/Group Description:
A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
Overall Number of Participants Analyzed 53 46
Mean (95% Confidence Interval)
Unit of Measure: pmol/L
Weel 12
-1.0
(-1.4 to -0.5)
3.0
(1.2 to 4.9)
Week 24
-0.8
(-1.4 to -0.1)
3.3
(1.8 to 4.7)
Week 48
-0.2
(-0.9 to 0.4)
10.0
(5.0 to 15.0)
6.Secondary Outcome
Title Effects on Carotid Artery Wall Thickness
Hide Description Changes in common carotid artery intima-media thickness, assessed by ultrasonography.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atenolol Irbesartan
Hide Arm/Group Description:
A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
Overall Number of Participants Analyzed 56 52
Mean (Standard Deviation)
Unit of Measure: mm
0.03  (0.12) -0.01  (0.10)
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.
Adverse Event Reporting Description Defied and reported according to study protocol.
 
Arm/Group Title Irbesratan Atenolol
Hide Arm/Group Description A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
All-Cause Mortality
Irbesratan Atenolol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Irbesratan Atenolol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/56 (8.93%)      5/58 (8.62%)    
Cardiac disorders     
inadequate blood pressure reduction  [1]  2/56 (3.57%)  2 0/58 (0.00%)  0
Social circumstances     
events were not documented specifically in the records available   3/56 (5.36%)  3 5/58 (8.62%)  5
Indicates events were collected by systematic assessment
[1]
None of withdrawals were considered likely related to the drugs studied.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Irbesratan Atenolol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/56 (0.00%)      0/58 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Kahan, MD
Organization: Karolinska Institutet, Stockholm, Sweden
Phone: +46 8 123 568 61
EMail: thomas.kahan@ds.se
Publications of Results:
Layout table for additonal information
Responsible Party: Thomas Kahan, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00389168     History of Changes
Other Study ID Numbers: CV131-052
First Submitted: October 17, 2006
First Posted: October 18, 2006
Results First Submitted: August 19, 2012
Results First Posted: May 5, 2015
Last Update Posted: May 5, 2015