---
title: A Year Long Study to Evaluate the Safety of the Combination of Valsartan (320 mg) and Amlodipine (5 mg) in Patients With Hypertension
nct_id: NCT00170976
overall_status: COMPLETED
phase: PHASE3
sponsor: Novartis
study_type: INTERVENTIONAL
primary_condition: HYPERTENSION
countries: Germany, Switzerland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00170976.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00170976"
ct_last_update_post_date: 2023-10-12
last_seen_at: "2026-05-12T06:01:43.020Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Year Long Study to Evaluate the Safety of the Combination of Valsartan (320 mg) and Amlodipine (5 mg) in Patients With Hypertension

**Official Title:** A 54 Week, Extension to the Double-blind, Multicenter, Multifactorial, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Valsartan (160 mg and 320 mg) and Amlodipine (10 mg) Combined and Alone in Hypertensive Patients

**NCT ID:** [NCT00170976](https://clinicaltrials.gov/study/NCT00170976)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 403
- **Lead Sponsor:** Novartis
- **Conditions:** HYPERTENSION
- **Start Date:** 2004-04
- **Completion Date:** 2005-06
- **CT.gov Last Update:** 2023-10-12

## Brief Summary

A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2307.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL

```
Inclusion Criteria:

* SUCCESSFUL COMPLETION OF VAA489A2307 CORE TRIAL
* VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg

Exclusion Criteria:

* PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2307 CORE

Other protocol-defined exclusion criteria may apply.
```

## Interventions

- **valsartan + amlodipine** (DRUG)

## Primary Outcomes

- **Adverse events and serious adverse events at each study visit for 6 or 12 months**

## Secondary Outcomes

- **Change from baseline in diastolic blood pressure from baseline after 6 or 12 months**
- **Change from baseline in systolic blood pressure from baseline after 6 or 12 months**
- **Change from baseline in standing diastolic and systolic blood pressure after 6 or 12 months**
- **Change from baseline in sitting and standing pulse after 6 or 12 months**
- **Hematology and blood chemistry after 6 or 12 months**

## Locations (2)

- Sites in germany, Multiple Locations, Germany
- Novartis Pharmaceuticals, Basel, Switzerland

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.sites in germany|multiple locations||germany` — added _(2026-05-12)_
- `locations.novartis pharmaceuticals|basel||switzerland` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00170976.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00170976*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*