Aliskiren in Combination With Amlodipine in Hypertensive Patients Not Responding to Angiotensin Receptor Blocker (ARB) Plus Amlodipine

Essential Hypertension Clinical Trial

— AWESOME  

Official title:

An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of a 4 Week Therapy With the Single Pill (SPC) Combination of Aliskiren 300 mg / Amlodipine 10 mg in Hypertensive Patients Not Adequately Respond to an Uptitrated 4 Week Therapy With the SPC of Olmesartan 40 mg / Amlodipine 10 mg, With a Potential Extension if Patients Still Not Adequately Respond With a 4 Week Therapy With the SPC Aliskiren 300 mg / Amlodipine 10 mg / HCTZ 12,5 mg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113047
• Other study ID #: CSPA100ADE01
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2010
• Last updated: December 5, 2013
• Start date: May 2010

Study information

• Verified date: December 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy and safety of the single pill combination of Aliskiren and Amlodipine in patients with moderate hypertension not adequately responding to a single pill combination of Olmesartan and Amlodipine.

Further this study will also assess the efficacy and safety of a single pill combination of Aliskiren, Amlodipine and Hydrochlorothiazide (HCTZ) in patients with moderate hypertension not adequately responding to a single pill combination of Aliskiren and Amlodipine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Essential hypertension stage II

• Male and female patients

• Age >= 18 years old

Exclusion Criteria:

• Severe hypertension (systolic BP >= 180 mmHg, diastolic BP >= 110 mmHg

• Poorly controlled diabetes mellitus or type 1 DM

• History of myocardial infarction, stroke

• Presence of heart failure

• Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ
Aliskiren 300 mg / Amlodipine 10 mg/HCTZ 12.5 mg

Locations

Country	Name	City	State
Germany	Investigative Site	Pirna

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean sitting diastolic blood pressure after 4 weeks of treatment		4 weeks	No
Secondary	Change in mean sitting systolic blood pressure reduction after 4 weeks of treatment with Aliskiren/Amlodipine or after 4 weeks of treatment with Aliskiren/Amlodipine/HCT		4 weeks	No
Secondary	Change in mean sitting diastolic blood pressure after 4 weeks of treatment with Aliskiren/Amlodipine/HCT		4 weeks	No
Secondary	Change in heart rate, pulse pressure, responder rates, normalization rates after 4 weeks of treatment with Aliskiren/Amlodipine or after 4 weeks of treatment with Aliskiren/Amlodipine/HCT		4 weeks	No