NCT00409760

Brief Summary

This trial will compare valsartan and amlodipine combination therapies to both valsartan and amlodipine, and placebo for the treatment of hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,930

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Jan 2003

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

January 1, 2003

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2006

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

December 7, 2006

Last Update Submit

October 11, 2023

Conditions

Hypertension

Keywords

HYEPRTENSION, VALSARTAN, AMLODIPINE, high blood pressure

Outcome Measures

Primary Outcomes (1)

  • Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough (Wk 4 and Wk 8)

Secondary Outcomes (3)

  • Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough (Wk 4 and Wk 8)

  • Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough(Wk 4 and Wk 8)

  • Sitting and standing pulse

Interventions

valsartan+amlodipine combination, valsartan, amlodipineDRUG

Eligibility Criteria

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

You may qualify if:

  • Outpatients 18 years and older.
  • Male or female patients are eligible.
  • Female patients must be either post-menopausal for one year or surgically sterile, or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Hormonal contraceptive use is disallowed.
  • Patients with mild to moderate essential diastolic hypertension (grades 1 and 2 WHO classification) measured by calibrated standard sphygmomanometer.
  • Patients must have a MSDBP \>= 90 mmHg and \< 110 mmHg at Visit 1 (week -2 to -4), and a MSDBP \>= 95 mmHg and \< 110 mmHg at Visit 2 (week 0).
  • Patients must have an absolute difference of =\< 10 mmHg in their average sitting diastolic blood pressure between Visits 1 and 2.
  • Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).

You may not qualify if:

  • Severe hypertension (grade 3 WHO classification; MSDBP \>=110 mmHg diastolic and/or MSSBP \>= 180 mmHg systolic).
  • Inability to discontinue all prior anti-hypertensive medications safely for a period of 14 weeks).
  • Known Keith-Wagener grade III or IV hypertensive retinopathy.
  • History of hypertensive encephalopathy or cerebrovascular accident at anytime prior to Visit 1 (week -2 to -4).
  • Transient ischemic cerebral attack during the last 12 months prior to Visit 1 (week -2 to -4).
  • Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral renal artery stenosis, or pheochromocytoma, etc.
  • Type 1 Diabetes Mellitus.
  • Type 2 Diabetes Mellitus with poor glucose control as defined by fasting glycosylated hemoglobin (HbA1c) \>8% at Visit 1 (week -2 to -4).
  • Administration of any agent indicated for the treatment of hypertension within a minimum 4 weeks prior to randomization into the study (Visit 2, week 0), with the permitted exception of those anti-hypertensive medications requiring tapering down commencing at Visit 0 (week -4 to -6).
  • Known or suspected contraindications, including history of allergy to angiotensin receptor blockers or calcium channel blockers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sites in Germany

Multiple Locations, Germany

Location

Related Links

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

    Sponsor GmbH

    STUDY CHAIR

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

December 7, 2006

First Posted

December 11, 2006

Study Start

January 1, 2003

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

October 12, 2023

Record last verified: 2023-10

Locations

DE(1)