Pharmacokinetic Drug Interaction Study Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension

NCT00548067 | Completed Phase 3

• 1 other identifier: CVEA489A2104
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to determine potential pharmacokinetic drug-drug interaction when three drugs (valsartan, amlodipine, and hydrochlorothiazide) are co-administered.

Conditions

Hypertension

Keywords

High blood pressure, hypertension, drug interaction, steady state, valsartan, hydrochlorothiazide, amlodipine

Outcome Measures

Primary Outcomes (1)

• Potential drug interaction and effect on blood level of drugs when co-administered for 17 days

Secondary Outcomes (1)

• Safety and tolerability of co-administered assessed by capturing adverse events and safety laboratory

Study Arms (4)

1

ACTIVE COMPARATOR

Drug: Valsartan/hydrochlorothiazide (HCTZ)

2

ACTIVE COMPARATOR

Drug: Valsartan/amlodipine

3

ACTIVE COMPARATOR

Drug: Amlodipine/hydrochlorothiazide(HCTZ)

4

EXPERIMENTAL

Drug: Valsartan/amlodipine/hydrochlorothiazide(HCTZ)

Interventions

Valsartan/hydrochlorothiazide (HCTZ) DRUG

1

Valsartan/amlodipine DRUG

2

Amlodipine/hydrochlorothiazide(HCTZ) DRUG

3

Valsartan/amlodipine/hydrochlorothiazide(HCTZ) DRUG

4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Patients diagnosed as hypertensive
• Untreated confirmed hypertensive patients (consistent SBP \>140 mm Hg or DBP \>90 mm Hg)
• Uncontrolled hypertensive patients (Consistent SBP \>140 mm Hg or DBP \>90 mm Hg) on one drug therapy.
• Uncontrolled hypertensive patients (Consistent SBP \>140 mm Hg or DBP \>90 mm Hg) on two drug therapy.

You may not qualify if:

• Inability to switch from all prior antihypertensive medications safely as required by the protocol.
• Need for drugs other than study drugs at the time of baseline.
• Patients with SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at screening.
• Patients on four or more antihypertensive drugs at screening.
• Pregnant or nursing (lactating) women.
• Patients with diabetes mellitus
• Patients with heart diseases and any other disease

Sponsors & Collaborators

• Novartis: lead

Study Sites (5)

Novartis Investigative Site

Ahmedabad, India

Location

Novartis investigative site

Bangalore, India

Location

Novartis Investigative site

Hyderabad, India

Location

Novartis Investigative site

Mangalore, India

Location

Novartis investigative site

Mehasana, India

Location

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan; Hydrochlorothiazide; Amlodipine, Valsartan Drug Combination; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dihydropyridines; Pyridines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Novartis

  Novartis investigative site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 22, 2007
• First Posted: October 23, 2007
• Study Start: September 1, 2007
• Study Completion: March 1, 2008
• Last Updated: September 27, 2010

Record last verified: 2010-09

Locations

IN (5)