NCT00304226

Brief Summary

The population for this current study will include stage 1 and stage 2 hypertensive patients who are newly diagnosed or didn't have treatment during the last 3 months and patients who are currently treated but uncontrolled on present monotherapy. The purpose of this study is to evaluate the efficacy of a treatment with valsartan versus a treatment with amlodipine in reaching blood pressure control after 14 weeks of treatment.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,288

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_4 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

February 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

11 months

First QC Date

March 16, 2006

Last Update Submit

November 15, 2016

Conditions

Hypertension

Keywords

Valsartan,amlodipine,hydrochlorothiazide

Outcome Measures

Primary Outcomes (1)

  • Blood pressure less than 140/90 mmHg after 14 weeks

Secondary Outcomes (5)

  • Blood pressure less than 140/90 mmHg after 4, 8, and 11 weeks

  • Blood pressure less than 140/90 mmHg after 4, 8, 11, and 14 weeks

  • Time when blood pressure reaches less than 140/90 mmHg

  • Change in blood pressure at baseline, week 4, 8, 11, and 14

  • Adverse events and serious adverse events at each study visit for 14 weeks

Interventions

valsartanDRUG
amlodipineDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

  • Zappe D, Papst CC, Ferber P; PROMPT Investigators. Randomized study to compare valsartan +/- HCTZ versus amlodipine +/- HCTZ strategies to maximize blood pressure control. Vasc Health Risk Manag. 2009;5:883-92. doi: 10.2147/vhrm.s8062. Epub 2009 Nov 2.

    PMID: 19898644RESULT

MeSH Terms

Conditions

Hypertension

Interventions

ValsartanAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialDihydropyridinesPyridines

Study Officials

  • Novartis Pharmaceuticals

    Novatis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2006

First Posted

March 17, 2006

Study Start

February 1, 2006

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

November 16, 2016

Record last verified: 2016-11

Locations

CH(1)DE(1)