ALiskiren or Losartan Effects on bioMARKers of Myocardial... | NCT01176032

NCT01176032

ID	Type	Description	Link
2009-016735-36	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aliskiren	Experimental	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks. In addition to the study medication, amlodipine 5mg was given to patients who did not achieve the required blood pressure (<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication. At week 18 the dose of amlodipine was increased to 10mg if the required level (<140/90 mmHg) was still not achieved. HCTZ 12.5mg was prescribed at week 26 if the required values (<140/90 mmHg) had not been reached.	Drug: Aliskiren Drug: Amlodipine Drug: Hydrochlorothiazide (HCTZ)
Lostaran	Active Comparator	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks. In addition to the study medication, amlodipine 5mg was given to patients who did not achieve the required blood pressure (<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication. At week 18 the dose of amlodipine was increased to 10mg if the required level (<140/90 mmHg) was still not achieved. HCTZ 12.5mg was prescribed at week 26 if the required values (<140/90 mmHg) had not been reached.	Drug: Losartan Drug: Amlodipine Drug: Hydrochlorothiazide (HCTZ)

Name	Type	Description	Arm Group Labels	Other Names
Aliskiren	Drug	Aliskiren 300 mg film coated tablets	Aliskiren	Rasilez

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP)	PICP is a measure of blood concentration of procollagen I carboxy-terminal propeptide (PICP), a peptide released from the myocardium when procollagen is converted to type I collagen. This biomarker exhibits good specificity and sensitivity for identifying myocardial fibrosis in hypertension.	Baseline, Week 36

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Biomarkers in Heart Disease	The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Sanlúcar de Barrameda	Andalusia	11540	Spain
Novartis Investigative Site

References Module

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No data is available for this block.

IPD Sharing Statement Module

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No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
FG001	Lostaran	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG00037 subjects"Started" indicates randomized and safety population

Intention-to-treat (ITT) population

Arm/Group Information

ID	Title	Description
BG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
BG001	Lostaran	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG000-5.22± 20.37 OG001-4.25± 24.80

Secondary

Change From Baseline in Biomarkers in Heart Disease

The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)

Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.

Posted

Mean

Standard Deviation

ng/ml

Baseline, Week 36

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Lostaran	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks

Units	Counts
Participants

Secondary

Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease

The plasma level of biomarker parameter (aldosterone (Aldo)) used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI)

Posted

Mean

Standard Deviation

ng/dl

Baseline, Week 36

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Lostaran	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule

Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule

Posted

Mean

Standard Deviation

Baseline, Week 36

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Lostaran	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson)

Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)

Posted

Mean

Standard Deviation

Percent

Baseline, Week 36

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Lostaran	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter

Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter

Posted

Mean

Standard Deviation

mm/m^2

Baseline, Week 36

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Lostaran	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method)

Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)

Posted

Mean

Standard Deviation

cm3/m^2

Baseline, Week 36

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Lostaran	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI)

Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI

Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment

Posted

Mean

Standard Deviation

g/m^2

Baseline, Week 36

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Lostaran	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease.

Posted

Mean

Standard Deviation

ng/ml

Baseline, Week 36

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Aliskiren + Amlodipine	5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
OG002	Losartan

Secondary

Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine

The plasma level of biomarker parameter plasma aldosterone used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI).

Posted

Mean

Standard Deviation

ng/dl

Baseline, Week 36

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Aliskiren + Amlodipine	5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
OG002	Losartan	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks

Secondary

Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine

Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule

Posted

Mean

Standard Deviation

Baseline, Week 36

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Aliskiren + Amlodipinet	5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
OG002	Losartan	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks

Secondary

Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine

Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)

Posted

Mean

Standard Deviation

Percent

Baseline, Week 36

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Aliskiren + Amlodipinet	5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
OG002	Losartan	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks

Secondary

Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine

Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter

Posted

Mean

Standard Deviation

mm/m^2

Baseline, Week 36

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Aliskiren + Amlodipinet	5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
OG002	Losartan	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
OG003

Secondary

Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine

Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)

Posted

Mean

Standard Deviation

cm3/m^2

Baseline, Week 36

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Aliskiren + Amlodipinet	5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
OG002	Losartan	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks

Secondary

Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine

Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI

Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment

Posted

Mean

Standard Deviation

g/m2

Baseline, Week 36

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Aliskiren + Amlodipinet	5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
OG002	Losartan	losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
OG003	Losartan + Amlodipine

Secondary

Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP)

The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values

Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment

Posted

Mean

Standard Deviation

mmHg

Baseline, Week 10,18,26,36

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Lostaran	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks

Units	Counts
Participants	OG000

Secondary

Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP)

Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment

Posted

Mean

Standard Deviation

mmHg

Baseline, Week 10,18,26,36

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Lostaran	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks

Units	Counts
Participants	OG000

Secondary

Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate

Response rate was defined as the proportion of patients with a satisfactory systolic BP response (SBP < 140 mmHg or reduction of ≥ 10 mmHg compared to baseline) and a satisfactory diastolic BP response (DBP < 90 mmHg or reduction of ≥ 5 mmHg compared to baseline)

Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment

Posted

Number

Patients

Baseline, Week10,18,26,36

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Lostaran	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks

Units	Counts
Participants	OG000

Secondary

Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline

The control rate was defined as the proportion of patients with SBP < 140 mmHg and DBP < 90 mmHg compared to baseline

Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment

Posted

Number

Patients

Week10,18,26,36

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Lostaran	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks

Units	Counts
Participants	OG000

Secondary

Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs

The rate of use of first and second antihypertensive rescue drugs added was also assessed at all visits after week 2. The rescue drug at week 10 and 18 for those patients not achieving the required BP was amlodipine, Patients who did not achieve the required BP at week 26 were treated with hydrochlorothiazide

Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment

Posted

Number

Patients

Baseline, Week 10,18,26

ID	Title	Description
OG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
OG001	Lostaran	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Aliskiren	Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks			2	37	12	37
EG001	Losartan	Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks			0	37	16	37

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Bronchopneumonia	Infections and infestations	MedDRA	Systematic Assessment		EG0001 affected37 at risk EG0010 affected37 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA	Systematic Assessment		EG0001 affected37 at risk EG0010 affected37 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Palpitations	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected37 at risk EG0015 affected37 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected37 at risk EG0010 affected37 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected37 at risk EG0012 affected37 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected37 at risk EG0012 affected37 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0003 affected37 at risk EG0010 affected37 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected37 at risk EG0012 affected37 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected37 at risk EG0013 affected37 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected37 at risk EG0014 affected37 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected37 at risk EG0013 affected37 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected37 at risk EG0012 affected37 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected37 at risk EG0012 affected37 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 affected37 at risk EG0013 affected37 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 affected37 at risk EG0016 affected37 at risk
Renal colic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected37 at risk EG0011 affected37 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected37 at risk EG0010 affected37 at risk

ID	Term
D006973	Hypertension

ID	Term
C446481	aliskiren
D019808	Losartan
D017311	Amlodipine
D006852	Hydrochlorothiazide

Ancestor Terms

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D013777	Tetrazoles
D004095	Dihydropyridines
D011725	Pyridines
D002740	Chlorothiazide
D001581	Benzothiadiazines
D013449	Sulfonamides
D013450	Sulfones
D013457	Sulfur Compounds
D049971	Thiazides
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks

5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases