NCT00350168

Brief Summary

The purpose of this study is to evaluate the blood pressure lowering effects of a valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of stage II hypertensive patients (MSSBP ≥ 160 mmHg).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
647

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_3 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

June 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

10 months

First QC Date

July 7, 2006

Last Update Submit

November 16, 2016

Conditions

Hypertension

Keywords

Blood pressureVenous pressureSystolic pressureDiastolic pressurePulse pressure

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in MSSBP at week 4

Secondary Outcomes (4)

  • Change from baseline MSSBP after 2 and 8 weeks of treatment

  • Change from baseline MSDBP after 2, 4 and 8 weeks of treatment

  • Proportion of patients reaching overall BP control (MSSBP < 140 mmHg and MSDBP < 90mmHg) after 8 weeks of treatment

  • Evaluation of safety and tolerability after 8 weeks of treatment

Interventions

valsartan + amlodipineDRUG

Eligibility Criteria

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

You may qualify if:

  • years of age or older.
  • Moderate to severe high blood pressure. This is defined as a systolic pressure (the top number) greater than or equal to 160 mmHg and less than 200 mmHg.

You may not qualify if:

  • History of allergy or hypersensitivity to ARBs, CCBs, thiazide diuretics
  • Inability to stop all prior blood pressure medications safely
  • Systolic BP ≥ 200 mmHg and/or diastolic BP ≥ 120 mmHg
  • Controlled blood pressure (systolic BP \< 140 mmHg) taking more than 3 antihypertensive medications at screening
  • Systolic BP ≥ 140 mmHg and \< 180 mmHg taking more than two antihypertensive medications at screening
  • Systolic BP ≥ 180 mmHg taking more than one antihypertensive medication at screening
  • History of stroke, angioplasty, coronary artery bypass graft surgery, heart attack or unstable angina
  • Type 1 diabetes
  • Poorly controlled Type 2 diabetes
  • History of heart failure
  • Arrhythmia
  • Significant valvular heart disease
  • Active gout
  • History of autoimmune diseases
  • History of multiple drug allergies
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals Corp

East Hanover, New Jersey, 07936, United States

Location

Related Publications (1)

  • Destro M, Luckow A, Samson M, Kandra A, Brunel P. Efficacy and safety of amlodipine/valsartan compared with amlodipine monotherapy in patients with stage 2 hypertension: a randomized, double-blind, multicenter study: the EX-EFFeCTS Study. J Am Soc Hypertens. 2008 Jul-Aug;2(4):294-302. doi: 10.1016/j.jash.2008.01.004. Epub 2008 Jun 2.

    PMID: 20409909RESULT

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine, Valsartan Drug Combination

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ValsartanTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAmlodipineDihydropyridinesPyridinesValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialDrug CombinationsPharmaceutical Preparations

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2006

First Posted

July 10, 2006

Study Start

June 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

US(1)