NCT01241487

Brief Summary

This study is to assess the efficacy of the fixed combination of Valsartan and Amlodipine in hypertensive patients uncontrolled by monotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2009

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

February 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.9 years

First QC Date

November 15, 2010

Last Update Submit

February 21, 2017

Conditions

Primary Hypertension

Keywords

Hypertension, Valsartan/Amlodipine,

Outcome Measures

Primary Outcomes (1)

  • Hypertension in patients that will be controlled on each concentration and those that will switch to the higher concentration (160/10)

    4 weeks

Secondary Outcomes (3)

  • Hypertension of patients that were previously controlled on (160/5) and those that were uncontrolled and switched to the higher concentration (160/10) after 4 weeks on (160/5) concentration.

    8 weeks

  • Safety and Tolerability of the Trial Medication

    8 weeks

  • The incidence of Edema

    8 weeks

Study Arms (1)

1

EXPERIMENTAL

valsartan/amlodipine

Drug: valsartan/amlodipine

Interventions

valsartan/amlodipineDRUG

160/10 mg

1

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient uncontrolled by mono-therapy for at least 8 weeks, having B.P.\>/= 140/90 mmHg in non diabetics or \>/= 130/80 mmHg in diabetics

You may not qualify if:

  • Patient having B.P.\>= 180/110 mmHg in non diabetics or \>= 160/100 mmHg in diabetics
  • Type 1 Diabetes or uncontrolled type 2 Diabetes.
  • PCI in last 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Ahmed Anwar Clinic,

Cairo, Egypt

Location

MeSH Terms

Conditions

Essential HypertensionHypertension

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 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 16, 2010

Study Start

February 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

EG(1)