ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling

NCT01176032 | Completed Phase 4 Results

• 2 other identifiers: CSPP100AES022009-016735-36
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 25

Brief Summary

The purpose of this study is to assess efficacy of aliskiren for reducing circulating levels of biomarkers of left ventricular (LV) remodeling associated with LV hypertrophy (LVH) in hypertensive patients.

Conditions

Hypertension; Left Ventricle Hypertrophy

Keywords

Aliskiren; hypertension; concentric LVH; LV remodeling; LVMI; biomarkers; PICP; CT-1; MMP-1; TIMP-1; AnxA5; Aldosterone; Essential hypertension with concentric left ventricle hypertrophy

Outcome Measures

Primary Outcomes (1)

• 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 (19)

• Change From Baseline in Biomarkers in Heart Disease

  Baseline, Week 36

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

  Baseline, Week 36

• 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

  Baseline, Week 36

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

  Baseline, Week 36

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

  Baseline, Week 36

Study Arms (2)

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)

Interventions

Aliskiren DRUG

Aliskiren 300 mg film coated tablets

Also known as: Rasilez

Aliskiren

Losartan DRUG

Losartan 100 mg tablets

Lostaran

Amlodipine DRUG

Amlodipine 5mg was given to patients who did not achieve the required blood pressure (\<140/90 mmHg) after 8 weeks (visit 3)of treatment at the maximum doses of study medication in addition to the study medication in order to reach the required BP. at visit 4 (week 18) the dose of amlodipine was increased to 10mg if the required level (\<140/90 mmHg) was still not achieved.

Aliskiren; Lostaran

Hydrochlorothiazide (HCTZ) DRUG

HCTZ 12.5mg was prescribed at visit 5 (week 26) if the required values (\<140/90 mmHg) had not been reached.

Aliskiren; Lostaran

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with hypertension
• Confirmed concentric left ventricular hypertrophy:
• LVMI \> 49.2 g/m2.7 for men and \>46.7 g/m2.7 for women
• Relative wall thickness \> 0.42

You may not qualify if:

• Sever or secondary HTN
• LV ejection fraction of \<40%
• Patient with compelling indication to ACEIs or ARBs or BB
• History of myocardial infarction, coronary artery bypass surgery, PTC intervention, TIA or stroke within 6 months of study entry
• History of collagenopathies, osteopathy
• eGFR \<30 ml/min/1,73 m2, serum potassium ≥5,2 mEq/L
• Morbid obesity (BMI ≥ 42 kg/m2

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (25)

Novartis Investigative Site

Sanlúcar de Barrameda, Andalusia, 11540, Spain

Location

Novartis Investigative Site

Seville, Andalusia, 41009, Spain

Location

Novartis Investigative Site

Seville, Andalusia, 41013, Spain

Location

Novartis Investigative Site

Utrera, Andalusia, 41710, Spain

Location

Novartis Investigative Site

Barcelona, Barcelona, 08025, Spain

Location

Novartis Investigative Site

Bilbao, Basque Country, 48013, Spain

Location

Novartis Investigative Site

Galdakano, Basque Country, 48960, Spain

Location

Novartis Investigative Site

Vitoria-Gasteiz, Basque Country, Spain

Location

Novartis Investigative Site

Burgos, Castille and León, 09005, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

Girona, Catalonia, 17007, Spain

Location

Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

Novartis Investigative Site

Santa Coloma de Gramanet, Catalonia, Spain

Location

Novartis Investigative Site

Santiago de Compostela, Galicia, 15706, Spain

Location

Novartis Investigative Site

Madrid, Madrid, 28009, Spain

Location

Novartis Investigative Site

Madrid, Madrid, 28035, Spain

Location

Novartis Investigative Site

Madrid, Madrid, 28040, Spain

Location

Novartis Investigative Site

Madrid, Madrid, 28041, Spain

Location

Novartis Investigative Site

Madrid, Madrid, 28046, Spain

Location

Novartis Investigative Site

Alicante, Valencia, 03004, Spain

Location

Novartis Investigative Site

Torrevieja (Alicante), Valencia, 03186, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46010, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46014, Spain

Location

Novartis Investigative Site

Barcelona, 08006, Spain

Location

Novartis Investigative Site

Santander, 39008, Spain

Location

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren; Losartan; Amlodipine; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Dihydropyridines; Pyridines; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: August 5, 2010
• Study Start: June 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 24, 2014
• Results First Posted: July 24, 2014

Record last verified: 2014-07

Locations

ES (25)