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

NCT01113047 | Completed Phase 3

• 1 other identifier: CSPA100ADE01
• Study Type: interventional
• Target: 347
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Essential Hypertension

Keywords

Hypertension; Aliskiren; Amlodipine

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (3)

• 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

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

  4 weeks

• 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

Study Arms (1)

Non responder Olmesartan/Amlodipine

EXPERIMENTAL

Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ

Drug: Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ

Interventions

Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ DRUG

Aliskiren 300 mg / Amlodipine 10 mg/HCTZ 12.5 mg

Non responder Olmesartan/Amlodipine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Investigative Site

Pirna, Germany

Location

Related Publications (1)

• 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.

  PMID: 27536431 DERIVED

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Interventions

aliskiren; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Axthelm, Dr. med.

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: April 29, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2010
• Last Updated: December 6, 2013

Record last verified: 2013-12

Locations

DE (1)