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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00777946
First received: October 20, 2008
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: Aliskiren 300 mg
Drug: Aliskiren/Amlodipine 300/5 mg
Drug: Aliskiren/Amlodipine 300/10 mg
Drug: Placebo to Aliskiren
Drug: Placebo to Aliskiren/Amlodipine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Eight-week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (300/5 mg and 300/10 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension Not Adequately Responsive to Aliskiren 300 mg Monotherapy

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline, End of Study (Week 8) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP) [ Time Frame: Baseline, End of Study (Week 8) ] [ Designated as safety issue: No ]
    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 msSBP at baseline from the msSBP at 8 weeks was calculated using an ANCOVA model with baseline as a covariate and treatment and region as two factors.

  • Number of Participants With Serious Adverse Events and Adverse Events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

    The number of participants with any Serious Adverse Event and the number of participants with Adverse Events in any system organ class.

    Additional information about Adverse Events can be found in the Adverse Event Section.


  • Percentage of Participants Achieving Blood Pressure Control [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, 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.

    Blood Pressure control was defined as having a mean sitting Diastolic Blood Pressure <90 and a mean sitting Systolic Blood Pressure <140.


  • Percentage of Participants Achieving a Diastolic Blood Pressure Response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, 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.

    A Diastolic Blood Pressure Response was defined as a mean sitting Diastolic Blood Pressure (msDBP) <90 mmHg or a ≥ 10 mmHg reduction in msDBP from baseline.


  • Percentage of Participants Achieving a Systolic Blood Pressure Response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, 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.

    A Systolic Blood Pressure Response was defined as a mean sitting Systolic Blood Pressure (msSBP) <140 mmHg or a ≥ 20 mmHg reduction in msSBP from baseline.



Enrollment: 818
Study Start Date: October 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren 300 mg/Amlodipine 5 mg
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
Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water.
Drug: Placebo to Aliskiren
Placebo to Aliskiren tablet taken orally once a day.
Experimental: Aliskiren 300 mg/Amlodipine 10 mg
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
Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water.
Drug: Placebo to Aliskiren
Placebo to Aliskiren tablet taken orally once a day.
Active Comparator: Aliskiren 300 mg
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
Aliskiren 300 mg tablet taken orally once a day with a glass of water.
Drug: Placebo to Aliskiren/Amlodipine
Placebo to Aliskiren/Amlodipine taken orally once a day.

  Eligibility

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777946

Locations
Estonia
Investigative site
Estonia, Estonia
France
Investigative site
France, France
Iceland
Investigative Site
Iceland, Iceland
India
Investigative Site
India, India
Italy
Investigative site
Italy, Italy
Korea, Republic of
Investigative Site
Republic of Korea, Korea, Republic of
Lithuania
Investigative Site
Lithuania, Lithuania
Spain
Investigative Site
Spain, Spain
Venezuela
Investigative Site
Venezuela, Venezuela
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00777946     History of Changes
Other Study ID Numbers: CSPA100A2303
Study First Received: October 20, 2008
Results First Received: December 13, 2010
Last Updated: June 30, 2011
Health Authority: Estonia: The State Agency of Medicine
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Iceland: Icelandic Medicines Control Agency
India: Ministry of Health
Italy: The Italian Medicines Agency
Lithuania: State Medicine Control Agency - Ministry of Health
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Spanish Agency of Medicines
Venezuela: Ministry of Health and Social Development

Keywords provided by Novartis:
Aliskiren, Amlodipine, Non-responder to aliskiren

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on July 22, 2014