NCT02062645

Brief Summary

The population that will be included in this study, will be regular Turkish hypertensive patients who are expected to consume sodium in high amounts. It is hypothesized that, in that population, amlodipine/valsartan will be effective at the same rate of blood pressure (BP) control rate as expected from literature.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

8 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, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 28, 2017

Completed
Last Updated

March 28, 2017

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

February 12, 2014

Results QC Date

November 15, 2016

Last Update Submit

February 7, 2017

Conditions

Essential Hypertension

Keywords

essential hypertension

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8

    Control rate of BP defined as BP lower than 140/90 mmHg at office visits

    At week 4 and 8

Secondary Outcomes (4)

  • Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8

    baseline, week 4, week 8

  • Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8

    baseline, week 4, week 8

  • Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8

    At week 4 and 8

  • SBP and DBP in Patients With High Sodium Intake at Week 4 and 8

    At week 4 and 8

Study Arms (1)

amlodipine/valsartan

EXPERIMENTAL

All patients will receive amlodipine/valsartan 5/160 mg daily in screening and up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (day 30) if their hypertension can not be controlled. The duration of treatment period is 8 weeks.

Drug: amlodipine/valsartan

Interventions

amlodipine/valsartanDRUG

Fixed combination of amlodipine and valsartan in tablet; 5/160/mg, 10/160 mg

amlodipine/valsartan

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female, above 18 years of age
  • Diagnosis of essential hypertension
  • Newly diagnosed,
  • Previously untreated, or Currently untreated (not on regular antihypertensive treatment during the previous at least 1-month period)
  • Written informed consent

You may not qualify if:

  • Known or suspected secondary hypertension
  • eGFR lower than 30 mL/min
  • Use of any other hypertension treatments during the enrollment and need for using the related treatments during the study phase
  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. (i.e. valsartan, amlodipine, hydrochlorothiazide)
  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
  • Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days until the expected PD effect has returned to baseline, whichever is longer.Pregnant or nursing (lactating) women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Novartis Investigative Site

Ankara, 06100, Turkey (Türkiye)

Location

Novartis Investigative Site

Çanakkale, Turkey (Türkiye)

Location

Novartis Investigative Site

Fatih / Istanbul, 34098, Turkey (Türkiye)

Location

Novartis Investigative Site

Kinikli / Denizli, 20070, Turkey (Türkiye)

Location

Novartis Investigative Site

Kocaeli, 41380, Turkey (Türkiye)

Location

Novartis Investigative Site

Malatya, 44280, Turkey (Türkiye)

Location

Novartis Investigative Site

Mersin, 33079, Turkey (Türkiye)

Location

Novartis Investigative Site

Talas / Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Amlodipine, Valsartan Drug Combination

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 14, 2014

Study Start

February 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 28, 2017

Results First Posted

March 28, 2017

Record last verified: 2017-02

Locations

TU(8)