ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling

NCT ID: NCT01176032

Last Updated: 2014-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-04-30

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.

Detailed Description

Blood pressure was measured 10 weeks after starting treatment (visit 3). All patients who did not achieve the required blood pressure (<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication were given 5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg).

The patient's blood pressure was assessed at visit 4 (week 18) and if it was still not at the required level (<140/90 mmHg), the dose of amlodipine was increased to 10 mg.

Blood pressure was again assessed at visit 5 (week 26) and if the required values had not been reached (<140/90 mmHg), a 12.5 mg dose of hydrochlorothiazide (HCTZ) was prescribed

Conditions

Hypertension; Left Ventricle Hypertrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aliskiren

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.

Group Type: EXPERIMENTAL

Aliskiren

Intervention Type: DRUG

Aliskiren 300 mg film coated tablets

Amlodipine

Intervention Type: 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.

Hydrochlorothiazide (HCTZ)

Intervention Type: DRUG

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

Lostaran

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.

Group Type: ACTIVE_COMPARATOR

Losartan

Intervention Type: DRUG

Losartan 100 mg tablets

Amlodipine

Intervention Type: 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.

Hydrochlorothiazide (HCTZ)

Intervention Type: DRUG

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

Interventions

Aliskiren

Aliskiren 300 mg film coated tablets

Intervention Type: DRUG

Losartan

Losartan 100 mg tablets

Intervention Type: DRUG

Amlodipine

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.

Intervention Type: DRUG

Hydrochlorothiazide (HCTZ)

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

Intervention Type: DRUG

Other Intervention Names

Rasilez

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Sanlúcar de Barrameda, Andalusia, Spain

Novartis Investigative Site

Seville, Andalusia, Spain

Novartis Investigative Site

Seville, Andalusia, Spain

Novartis Investigative Site

Utrera, Andalusia, Spain

Novartis Investigative Site

Barcelona, Barcelona, Spain

Novartis Investigative Site

Bilbao, Basque Country, Spain

Novartis Investigative Site

Galdakano, Basque Country, Spain

Novartis Investigative Site

Vitoria-Gasteiz, Basque Country, Spain

Novartis Investigative Site

Burgos, Castille and León, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

Girona, Catalonia, Spain

Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, Spain

Novartis Investigative Site

Santa Coloma de Gramanet, Catalonia, Spain

Novartis Investigative Site

Santiago de Compostela, Galicia, Spain

Novartis Investigative Site

Madrid, Madrid, Spain

Novartis Investigative Site

Madrid, Madrid, Spain

Novartis Investigative Site

Madrid, Madrid, Spain

Novartis Investigative Site

Madrid, Madrid, Spain

Novartis Investigative Site

Madrid, Madrid, Spain

Novartis Investigative Site

Alicante, Valencia, Spain

Novartis Investigative Site

Torrevieja (Alicante), Valencia, Spain

Novartis Investigative Site

Valencia, Valencia, Spain

Novartis Investigative Site

Valencia, Valencia, Spain

Novartis Investigative Site

Barcelona, , Spain

Novartis Investigative Site

Santander, , Spain

Countries

Spain

Other Identifiers

2009-016735-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSPP100AES02

Identifier Type: -

Identifier Source: org_study_id