NCT00778921

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
847

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_3 hypertension

Geographic Reach
7 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 23, 2011

Completed
Last Updated

October 27, 2016

Status Verified

February 1, 2011

Enrollment Period

8 months

First QC Date

October 23, 2008

Results QC Date

December 13, 2010

Last Update Submit

September 20, 2016

Conditions

Hypertension

Keywords

AliskirenAmlodipineNon-responder to Amlodipine

Outcome Measures

Primary Outcomes (1)

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

    Baseline and Week 8

Secondary Outcomes (3)

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

    Baseline and Week 8

  • Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group

    8 weeks

  • Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS)

    12 weeks

Study Arms (3)

Amlodipine 10 mg

EXPERIMENTAL

Amlodipine 10 mg

Drug: Amlodipine 10 mg

Aliskiren/Amlodipine 150/10 mg

EXPERIMENTAL

Aliskiren/Amlodipine 150/10 mg

Drug: Amlodipine 10 mgDrug: Aliskiren 150

Aliskiren/Amlodipine 300/10 mg

EXPERIMENTAL

Aliskiren/Amlodipine 300/10 mg

Drug: Amlodipine 10 mgDrug: Amlodipine 300

Interventions

Amlodipine 10 mgDRUG

Amlodipine 10 mg

Aliskiren/Amlodipine 150/10 mgAliskiren/Amlodipine 300/10 mgAmlodipine 10 mg
Aliskiren 150DRUG

Aliskiren/Amlodipine 150/10 mg

Aliskiren/Amlodipine 150/10 mg
Amlodipine 300DRUG

Aliskiren/Amlodipine 300/10 mg

Aliskiren/Amlodipine 300/10 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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 5 (randomization)

You may not qualify if:

  • Severe hypertension
  • Pregnant or nursing (lactating) women
  • Pre-menopausal women not taking accepted form of birth control
  • Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
  • History of cardiovascular conditions
  • Uncontrolled Type 1 or Type 2 diabetes mellitus
  • Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Investigative Site

Buenos Aires, Argentina

Location

Investigative Site

Berlin, Germany

Location

Investigative Site

Oslo, Norway

Location

Investigative Site

Warsaw, Poland

Location

Investigative Site

Bratislava, Slovakia

Location

Investigative Site

Stockholm, Sweden

Location

Investigative Site

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • Pfeiffer D, Rennie N, Papst CC, Zhang J. Efficacy and tolerability of aliskiren/amlodipine single-pill combinations in patients who did not respond fully to amlodipine monotherapy yen. Curr Vasc Pharmacol. 2012 Nov;10(6):773-80. doi: 10.2174/157016112803520945.

    PMID: 22303911DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis

    N

    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 23, 2008

First Posted

October 24, 2008

Study Start

October 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

October 27, 2016

Results First Posted

March 23, 2011

Record last verified: 2011-02

Locations

NO(1)PL(1)SE(1)TU(1)SL(1)AR(1)DE(1)