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Completed

NCT Number: NCT01113047

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

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Site

Pirna, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ

Drug

Aliskiren 300 mg / Amlodipine 10 mg/HCTZ 12.5 mg

Primary outcomes

  1. Change in mean sitting diastolic blood pressure after 4 weeks of treatment

    Time frame: 4 weeks

Secondary outcomes

  1. 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

    Time frame: 4 weeks

  2. Change in mean sitting diastolic blood pressure after 4 weeks of treatment with Aliskiren/Amlodipine/HCT

    Time frame: 4 weeks

  3. 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

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Acronym: AWESOME

Important dates

Study start
2010
Primary completion
2010
First posted
Apr 29, 2010
Registry last updated
Dec 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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