NCT00687973

Brief Summary

Assess that for an equivalent brachial blood pressure (BP)lowering, a fixed dose combination amlodipine/valsartan based regimen reduces central aortic BP pressure to a larger extent than an atenolol/amlodipine combination based regimen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
393

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_4 hypertension

Geographic Reach
1 country

1 active site

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

January 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 21, 2011

Completed
Last Updated

March 11, 2011

Status Verified

March 1, 2011

Enrollment Period

1 year

First QC Date

March 20, 2008

Results QC Date

December 22, 2010

Last Update Submit

March 8, 2011

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)

    Baseline and Week 24

Secondary Outcomes (10)

  • Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement)

    Baseline and Week 8

  • Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement)

    Baseline and Week 24

  • Change From Baseline of Augmentation Index (Aix) at Week 8

    Baseline and Week 8

  • Change From Baseline of Aix at Week 24

    Baseline and Week 24

  • Change From Baseline of Aix Corrected to Heart Rate at Week 24

    Baseline and Week 24

  • +5 more secondary outcomes

Study Arms (2)

Valsartan/amlodipine 160/10 mg

EXPERIMENTAL

Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.

Drug: Valsartan/amlodipine 80/5 mg tablets

Atenolol/amlodipine 100/10 mg

ACTIVE COMPARATOR

Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.

Drug: Amlodipine 5 mg capsulesDrug: Amlodipine 10 mg capsulesDrug: Atenolol 50 mg tabletsDrug: Atenolol 100 mg tablets

Interventions

Valsartan/amlodipine 80/5 mg tabletsDRUG
Valsartan/amlodipine 160/10 mg
Amlodipine 5 mg capsulesDRUG
Atenolol/amlodipine 100/10 mg
Amlodipine 10 mg capsulesDRUG
Atenolol/amlodipine 100/10 mg
Atenolol 50 mg tabletsDRUG
Atenolol/amlodipine 100/10 mg
Atenolol 100 mg tabletsDRUG
Atenolol/amlodipine 100/10 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients 18 years of age or older
  • Hypertension defined by MSDBP \> 90 and or MSSBP \> 140 mmHg, MSDBP \> 80 mmHg, or/and MSSBP \> 130 mmHg if diabetes or chronic renal impairment uncontrolled under their previous therapy, or untreated , or experiencing unacceptable side effects
  • Written informed consent to participate in the study prior to any study procedures

You may not qualify if:

  • Severe hypertension (grade 3 WHO classification MSDBP \> 110 mmHg and/or MSSBP \> 180 mmHg)
  • Evidence of a secondary form of hypertension
  • Type 1 diabetes mellitus
  • History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2 & 4 rue Lionel Terray BP 308

Rueil-Malmaison, 92506, France

Location

MeSH Terms

Conditions

Hypertension

Interventions

ValsartanAmlodipineAtenolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialDihydropyridinesPyridinesPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862 778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 20, 2008

First Posted

June 2, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

March 11, 2011

Results First Posted

January 21, 2011

Record last verified: 2011-03

Locations

FR(1)