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CompletedNCT01113047AWESOMEUpdated Dec 6, 2013

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

A Phase 3 interventional study of Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ in Essential Hypertension, sponsored by Novartis. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-06.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
347
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Essential Hypertension

Keywords

  • Hypertension
  • Aliskiren
  • Amlodipine
03

In context

Hypertension

6,690 studies on the registry are indexed under Hypertension; 966 are open to participants now.

This study's enrollment of 347 is above the median of 90 across 4,996 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Essential hypertension stage II
  • Male and female patients
  • Age >= 18 years old

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
347 participants (actual)

Study arms

  • Experimental
    Non responder Olmesartan/Amlodipine

    Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ

    Drug: Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ

Interventions

  • DrugAliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ

    Aliskiren 300 mg / Amlodipine 10 mg/HCTZ 12.5 mg

06

What researchers measure

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

07

Study locations

1 site
  • Investigative Site
    Pirna, Germany
08

References and documents

Publications

  • Axthelm C, Sieder C, Meister F, Pittrow D, Kaiser E. Aliskiren/amlodipine as a single-pill combination in hypertensive patients: subgroup analysis of elderly patients, with metabolic risk factors or high body mass index. J Drug Assess. 2012 Dec 25;2(1):1-10. doi: 10.3109/21556660.2012.762367. eCollection 2013. PubMed 27536431 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01113047
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
Apr 29, 2010
Start date
May 2010
Primary completion
Oct 2010
Last update
Dec 6, 2013

Study contacts

Axthelm, Dr. med.
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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