Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone

NCT00777946 | Completed Phase 3 Results

• 1 other identifier: CSPA100A2303
• Study Type: interventional
• Target: 818
• Locations: 8 countries
• Sites: 8

Brief Summary

This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone

Conditions

Hypertension

Keywords

Aliskiren, Amlodipine, Non-responder to aliskiren

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP)

  After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors.

  Baseline, End of Study (Week 8)

Secondary Outcomes (5)

• Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP)

  Baseline, End of Study (Week 8)

• Number of Participants With Serious Adverse Events and Adverse Events

  8 weeks

• Percentage of Participants Achieving Blood Pressure Control

  8 weeks

• Percentage of Participants Achieving a Diastolic Blood Pressure Response

  8 weeks

• Percentage of Participants Achieving a Systolic Blood Pressure Response

  8 weeks

Study Arms (3)

Aliskiren 300 mg/Amlodipine 5 mg

EXPERIMENTAL

Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.

Drug: Aliskiren/Amlodipine 300/5 mg; Drug: Placebo to Aliskiren

Aliskiren 300 mg/Amlodipine 10 mg

EXPERIMENTAL

Participants received 1 Aliskiren/Amlodipine 300/10 mg tablet + 1 Placebo to Aliskiren tablet orally once daily in the morning for 8 weeks.

Drug: Aliskiren/Amlodipine 300/10 mg; Drug: Placebo to Aliskiren

Aliskiren 300 mg

ACTIVE COMPARATOR

Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.

Drug: Aliskiren 300 mg; Drug: Placebo to Aliskiren/Amlodipine

Interventions

Aliskiren 300 mg DRUG

Aliskiren 300 mg tablet taken orally once a day with a glass of water.

Aliskiren 300 mg

Aliskiren/Amlodipine 300/5 mg DRUG

Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water.

Aliskiren 300 mg/Amlodipine 5 mg

Aliskiren/Amlodipine 300/10 mg DRUG

Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water.

Aliskiren 300 mg/Amlodipine 10 mg

Placebo to Aliskiren DRUG

Placebo to Aliskiren tablet taken orally once a day.

Aliskiren 300 mg/Amlodipine 10 mg; Aliskiren 300 mg/Amlodipine 5 mg

Placebo to Aliskiren/Amlodipine DRUG

Placebo to Aliskiren/Amlodipine taken orally once a day.

Aliskiren 300 mg

Eligibility Criteria

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

You may qualify if:

• Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a mean sitting Diastolic Blood Pressure (msDBP) ≥ 95 mmHg and \< 110 mmHg at Visits 1 and 2
• Patients who have been treated for hypertension within the 4 weeks prior to - Visit 1 must have a msDBP ≥ 90 mmHg and \< 110 mmHg at Visit 2
• All patients must have a msDBP ≥ 90 mmHg and \< 110 mmHg at Visit 4

You may not qualify if:

• Severe hypertension
• Pregnant or nursing (lactating) women
• Women of child-bearing potential
• Previous or current diagnosis of heart failure New York Heart Association (NYHA Class II-IV)
• Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
• Uncontrolled Type 1 or Type 2 diabetes mellitus
• Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
• History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention

Sponsors & Collaborators

• Novartis: lead

Study Sites (9)

Investigative site

Estonia, Estonia

Location

Investigative site

France, France

Location

Investigative Site

Iceland, Iceland

Location

Investigative Site

India, India

Location

Investigative site

Italy, Italy

Location

Investigative Site

Lithuania, Lithuania

Location

Investigative Site

Republic of Korea, South Korea

Location

Investigative Site

Spain, Spain

Location

Investigative Site

Venezuela, Venezuela

Location

Related Publications (1)

• Glorioso N, Thomas M, Troffa C, Argiolas G, Patel S, Baek I, Zhang J. Antihypertensive efficacy and tolerability of aliskiren/amlodipine single- pill combinations in patients with an inadequate response to aliskiren monotherapy. Curr Vasc Pharmacol. 2012 Nov;10(6):748-55. doi: 10.2174/157016112803520765.

  PMID: 22303910 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: October 22, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 12, 2011
• Results First Posted: June 15, 2011

Record last verified: 2011-06

Locations

VE (1); ES (1); LI (1); IT (1); FR (1); IC (1); IN (1); KR (1)