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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01113047
First received: April 27, 2010
Last updated: March 7, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Essential Hypertension
 Drug: Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ
 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in mean sitting diastolic blood pressure after 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change in mean sitting diastolic blood pressure after 4 weeks of treatment with Aliskiren/Amlodipine/HCT [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 347
Study Start Date: May 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non responder Olmesartan/Amlodipine
Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ
 Drug: Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ
Aliskiren 300 mg / Amlodipine 10 mg/HCTZ 12.5 mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113047

Locations
Germany
Investigative Site
Pirna, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Director: Axthelm, Dr. med. Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01113047     History of Changes
Other Study ID Numbers: CSPA100ADE01
Study First Received: April 27, 2010
Last Updated: March 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Hypertension
Aliskiren
Amlodipine

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Amlodipine
Olmesartan
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Calcium Channel Blockers
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers

ClinicalTrials.gov processed this record on May 23, 2013