NCT00170963

Brief Summary

This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,018

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Oct 2004

Shorter than P25 for phase_3 hypertension

Geographic Reach
2 countries

2 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, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

8 months

First QC Date

September 10, 2005

Last Update Submit

May 15, 2017

Conditions

Hypertension

Keywords

Hypertension, high blood pressure, valsartan, amlodipine

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcomes (3)

  • Change from baseline in mean systolic blood pressure after 8 weeks

  • Decrease in diastolic blood pressure of at least 10 mmHg or diastolic blood pressure was less than 90 mmHg after 8 weeks

  • Diastolic blood pressure less than 90 mmHg after 8 weeks

Interventions

valsartan/amlodipineDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients with uncomplicated, essential hypertension

You may not qualify if:

  • Severe hypertension
  • History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
  • Liver, kidney, or pancreas disease
  • Insulin dependent diabetes
  • Allergy to certain medications used to treat high blood pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Investigative Centers, Germany

Location

Novartis Pharmaceuticals

Basel, Switzerland

Location

Related Publications (1)

  • Sinkiewicz W, Glazer RD, Kavoliuniene A, Miglinas M, Prak H, Wernsing M, Yen J. Efficacy and tolerability of amlodipine/valsartan combination therapy in hypertensive patients not adequately controlled on valsartan monotherapy. Curr Med Res Opin. 2009 Feb;25(2):315-24. doi: 10.1185/03007990802630588.

    PMID: 19192976DERIVED

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

September 10, 2005

First Posted

September 15, 2005

Study Start

October 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

May 17, 2017

Record last verified: 2017-05

Locations

DE(1)CH(1)