NCT00939588

Brief Summary

This study is designed as a mechanistic study to compare the effect of two different combinations of anti-hypertensive treatments (aliskiren and valsartan vs. telmisartan and ramipril) on the renin-angiotensin-aldosterone system (RAAS) in patients with moderate hypertension.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P25-P50 for phase_2 hypertension

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

July 9, 2009

Last Update Submit

November 16, 2016

Conditions

Hypertension

Keywords

Aliskiren,hypertension,renin-angiotensin-aldosterone system

Outcome Measures

Primary Outcomes (1)

  • Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on 24-hour urinary aldosterone

    56 days

Secondary Outcomes (3)

  • Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on Plasma Renin Activity (PRA)and angiotensin II

    56 days

  • Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on mean sitting systolic and diastolic blood pressure

    56 days

  • Assess safety and tolerability of aliskiren + valsartan and ramipril + telmisartan

    56 days

Study Arms (2)

Aliskiren and Valsartan

EXPERIMENTAL
Drug: Aliskiren/ Valsartan

Telmisartan and Ramipril

ACTIVE COMPARATOR
Drug: Telmisartan/ Ramipril

Interventions

Aliskiren/ ValsartanDRUG
Aliskiren and Valsartan
Telmisartan/ RamiprilDRUG
Telmisartan and Ramipril

Eligibility Criteria

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

You may qualify if:

  • Males or females of non-childbearing potential, 18 to 65 years of age with moderate hypertension
  • Patients who are eligible and able to participate in the study

You may not qualify if:

  • Severe hypertension or secondary form of hypertension.
  • Serum potassium \> 5.1 mEq/L (mmol/L)
  • Heart failure
  • Any history of hypertensive encephalopathy or cerebrovascular accident; any history of TIA, myocardial infarction, coronary bypass surgery or percutaneous coronary intervention
  • Uncontrolled or life-threatening arrythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Moscow, Russia

Location

MeSH Terms

Conditions

Hypertension

Interventions

aliskirenValsartanTelmisartanRamipril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 9, 2009

First Posted

July 15, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2009

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

RU(1)