Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension

NCT00523744 | Completed Phase 3 Results

• 1 other identifier: CVAA489ADE06
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).

Conditions

Hypertension

Keywords

hypertension, valsartan, amlodipine

Outcome Measures

Primary Outcomes (2)

• Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study

  The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.

  Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)

• Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study

  The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.

  Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)

Secondary Outcomes (10)

• Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study

  Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)

• Change in Sitting Pulse Pressure During the Core Phase of the Study

  Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)

• Change in Sitting Pulse Rate During the Core Phase of the Study

  Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)

• Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study

  Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)

• Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study

  Baseline of Phase 2 (Week 4) to end of Phase 2 (Week 8)

Study Arms (1)

Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ

EXPERIMENTAL

During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.

Drug: Amlodipine; Drug: Olmesartan medoxomil; Drug: Amlodipine+valsartan; Drug: Hydrochlorothiazide

Interventions

Amlodipine DRUG

Amlodipine supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only.

Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ

Olmesartan medoxomil DRUG

Olmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only.

Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ

Amlodipine+valsartan DRUG

Fixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally once a day during Treatment Phase 2 and Extension Phase.

Also known as: Exforge

Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ

Hydrochlorothiazide DRUG

Hydrochlorothiazide (HCTZ) 12.5 mg tablets taken once a day during the Extension Phase.

Also known as: Sandoz

Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients (\>=18 years)
• Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods
• Patients with essential hypertension (diastolic blood pressure \>=100 mmHg and \<110 mmHg)
• \- Patients had to have a msSBP \>= 140 mmHg and/or msDBP \>= 90 mmHg at week 8 ie, end of core study.

You may not qualify if:

• Severe hypertension (diastolic blood pressure \>=110 mmHg or systolic blood pressure \>= 180 mmHg)
• Pregnant or nursing women
• Treated hypertensive patients with controlled hypertension under current therapy
• A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
• prematurely discontinued the core study
• failed to comply with the core study protocol

Sponsors & Collaborators

• Novartis: lead

Study Sites (2)

Novartis Investigative Site, , Germany

Schwerin, Germany

Location

30 sites in Germany

Location

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine; Olmesartan Medoxomil; Amlodipine, Valsartan Drug Combination; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Sponsor GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 30, 2007
• First Posted: August 31, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: August 4, 2020
• Results First Posted: May 25, 2011

Record last verified: 2020-07

Locations

DE (1)